Biocon's Kirsty Becomes Second Insulin Aspart Biosimilar to Receive U.S. FDA Approval

Just a few weeks ago, on July 15, 2025, Biocon Biologics announced that the U.S. Food and Drug Administration (FDA) had formally approved its Biologics License Application (BLA) for Kirsty™ (insulin aspart-xjhz), a biosimilar copy of Novo Nordisk's first-generation prandial insulin analogue branded as Novolog® (insulin aspart). The Biocon insulin aspart product will also be sold under other brand names through different marketing partnerships which Biocon has established. This means Kirsty joins Sanofi's Merilog as the second FDA-approved biosimilar insulin aspart in the U.S. in 2025. FDA has approved several copies of Lantus already, and now Novolog as well as one follow-on biologic copy of Humalog (specifically, Sanofi's Admelog). There are quite a few other biosimilar insulins which have yet to receive FDA approval decisions. I expected those to have decisions already, so FDA is running behind schedule rendering decisions on those products.

When Sanofi's insulin aspart biosimilar was approved earlier this year, FDA actually issued its own press release on the decision (see that release at https://www.prnewswire.com/news-releases/fda-approves-first-rapid-acting-insulin-biosimilar-product-for-treatment-of-diabetes-302377321.html for more), but since then, there have been unprecedented staff cuts at FDA which means no more FDA press releases about biosimilar insulins until the Trump/DOGE era with massive staff cuts is over. 

As a result, Biocon decided to issue its own press release on the FDA's approval of its insulin aspart biosimilar, and you can read Biocon's official announcement at https://www.globenewswire.com/news-release/2025/07/15/3115973/0/en/Biocon-Biologics-Expands-Diabetes-Portfolio-with-FDA-Approval-of-Kirsty-the-First-and-Only-Interchangeable-Rapid-Acting-Insulin-Aspart-in-the-United-States.html. The FDA approval letter which was sent to Biocon Biologics for Kirsty can be viewed at https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761188Orig1s000ltr.pdf. 

Biocon originally submitted Kirsty for FDA approval back on July 16, 2020, but in early 2023, the FDA issued a Complete Response Letter (CRL) to Biocon Biologics due to manufacturing concerns at its Johor, Malaysia facility. The FDA's feedback did not question the insulin aspart biosimilar's clinical data, but it cited procedural deficiencies related to the company's adherence to Good Manufacturing Protocol (GMP), particularly issues identified during an earlier inspection of the Johor, Malaysia facility where the insulin is actually manufactured. Until those issues were resolved to FDA's satisfaction, and the site was re-inspected by FDA, no other FDA approvals would be issued for any other insulin products made there. Biocon's 2023 CRL disclosure to shareholders can be viewed at https://www.biocon.com/biocon-biologics-receives-complete-response-letter-from-us-fda-for-biosimilar-insulin-aspart/. 

The successful 2025 insulin aspart FDA approval demonstrates Biocon's ability to successfully resolve those compliance issues without support from Viatris (formerly Mylan), which previously handled regulatory operations for the company's biosimilar joint venture. Biocon acquired Viatris' half of their biosimilar collaboration on November 29, 2022, assuming full responsibility for the regulatory process. The acquisition details are at https://www.prnewswire.com/news-releases/viatris-completes-biosimilars-transaction-with-biocon-biologics-301688467.html. 

Kirsty has already received regulatory approval for sale in more than 40 countries, including Canada, Japan, Australia, and across most of Europe. Health Canada granted its approval on October 12, 2021, and the insulin aspart biosimilar entered the Canadian market in 2022. It has also been approved in markets such as Germany, the UK, France, Spain, Portugal, the Netherlands, Norway, Denmark, Sweden, Finland, and Iceland. Documentation of Health Canada's approval is available at https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00570.

In the United States, Biocon has a commercial agreement with Civica, Inc., a nonprofit pharmaceutical organization created to offer insulin aspart only. Under this deal, Biocon will exclusively supply insulin aspart for Civica's U.S. insulin program. The other two insulins included in Civica's biosimilar insulin initiative — insulin glargine and insulin lispro — will continue to be manufactured by GeneSys Biologics of India. 

Civica will carry out all "fill and finish" operations at its newly built manufacturing facility in Petersburg, Virginia. It also has a confirmed device supply agreement for the UnoPen disposable insulin pen with Swiss company Ypsomed, which will be used across all three of Civica's insulin biosimilar offerings. Civica and Biocon's collaboration announcement can be viewed at https://www.prnewswire.com/news-releases/biocon-biologics-and-civica-inc-collaborate-to-expand-insulin-aspart-access-in-the-united-states-302394010.html. 

While Biocon has not publicly disclosed the specific injection pen device used for its branded Kirsty insulin pens (it already sells the glargine biosimilar Semglee in a pen device and presumably it will be the same model), regulatory filings and manufacturing locations suggest that the likely source is SHL Medical, which is a Swiss company that produces disposable insulin pens in Malaysia. SHL's Madie® device is the candidate that may be used for both Semglee and Kirsty pens. Information about SHL Medical and its Madie® pen can be seen at https://www.medicalexpo.com/prod/shl-healthcare/product-118709-835950.html. 

Although it has been selling Semglee since 2021, navigating the U.S. insulin market may still prove challenging for Biocon. The entrenched rebate-driven pricing system controlled by Pharmacy Benefit Managers (PBMs) means that companies must offer steep rebates to gain favorable formulary placement. When Viatris introduced Semglee on behalf of Biocon back in 2021, it had to dramatically raise the U.S. list price (by more that sixty-five per cent!) in order to meet the 75%+ rebate demands from PBM's such as Express Scripts and Prime Therapeutics. An overview of those rebate dynamics can be found at https://www.drugchannels.net/2021/11/why-pbms-and-payers-are-embracing.html. 

However, the insulin pricing landscape in the U.S. is now shifting. The American Rescue Plan of 2021 removed the cap on Medicaid rebates for drugs whose list prices outpace inflation, which historically allowed insulin makers to keep increasing prices to fund PBM rebates. Simultaneously, the Federal Trade Commission (FTC) launched litigation against major PBM's over anticompetitive contracting and formulary practices along with subsequent litigation against the PBM's. Discussion of these policy changes appears at https://progressivepolicyinstitute.medium.com/are-we-on-the-cusp-of-a-new-drug-pricing-paradigm-fdf611c009b3 and my own blog post found at https://blog.sstrumello.com/2025/01/why-i-pushed-for-ftc-litigation-against.html. 

Meanwhile, Civica's nonprofit insulin initiative, supported by funding from Breakthrough T1D (formerly known as JDRF), aims to bypass the PBM rebate model entirely by offering insulin aspart, glargine, and lispro at a maximum retail price of $30 per vial or $55 per box of five pens. The pricing strategy is meant to provide transparent, low-cost alternatives without formulary restrictions. More on Civica's insulin initiative is at https://blog.sstrumello.com/2022/03/civica-rx-were-entering-us-insulin.html, while Breakthrough T1D/JDRF's announcement of Civica's price commitments is available at https://www.prnewswire.com/news-releases/jdrf-announces-support-of-civica-to-manufacture-and-distribute-low-cost-insulin-301495050.html and Civica's own statement is at https://www.businesswire.com/news/home/20220303005321/en/Civica-to-Manufacture-and-Distribute-Affordable-Insulin. 

Following the FDA's approval of Biocon's Kirsty insulin aspart biosimilar, Novolog now becomes the second insulin analogue — after Sanofi's Lantus — to face competition from more than one biosimilar product from several different manufacturers in the U.S. In February 2025, Sanofi's Merilog became the first FDA-approved biosimilar of Novolog. Several more biosimilar versions of insulin aspart are still awaiting regulatory decisions, with applications currently pending from Sandoz/Gan & Lee, Amphastar/ANP, Lannett/HEC, and Meitheal/THDB a few years later. 

Commentary on my assessment of the backlog of biosimilar insulin drug decisions is available at https://blog.sstrumello.com/2025/01/ask-fda-why-arent-insulin-biosimilars.html. Reporting on recent major FDA staffing disruptions attributed to DOGE and current Department of HHS leadership can be seen at https://www.nytimes.com/2025/07/08/magazine/fda-collapse-rfk-kennedy.html. 

Just as it did with its glargine insulin biosimilar which is branded as Semglee, Biocon could theoretically offer both branded Kirsty sold via PBMs and a separate unbranded insulin aspart product in the U.S. (although with insulin list prices falling on all insulins in the U.S., see https://www.drugchannels.net/2025/01/inflation-adjusted-us-brand-name-drug.html for more on that development), an unbranded insulin aspart product may no longer be a necessity for Biocon; for example, Novo Nordisk announced it will be discontinuing its unbranded insulin products by the end of 2025), in multiple delivery formats including 10 mL vials as well as in disposable insulin pens. Although the company has not announced that it intends to sell Kirsty in a package of five 3 mL cartridges as an option for patients who prefer to use refillable smart pens such as the Medtronic InPen (a smart pen which logs insulin dosages and tracks insulin-on-board), theoretically 3 mL cartridges might have demand in the U.S. However, there was news that a self-filled injection device called the Go-Pen ApS recently received FDA clearance, and the 3 mL cartridges used with that product could be a work-around for that, although the product has not yet launched in the U.S. (see https://www.drugdeliverybusiness.com/go-pen-fda-nod-user-filled-insulin-pen/ for more). 

With rising pressure on insulin list pricing, increased regulatory scrutiny of PBM's unlawful behavior,  including from the Federal Trade Commission which is now suing the big PBMs and their rebate-contracting pharmaceutical sales model in the U.S., and the emergence of nonprofit options such as those from Civica, the dynamics of insulin pricing in the U.S. are finally shifting and list prices are falling in the U.S. The entry of multiple biosimilar insulin aspart products — especially those developed outside of (or working around) the rebate-contracting sales model — could mark a long-awaited turning point for U.S. insulin affordability. 

In my opinion, it is about time.

Platinum Equity Plans to Reorganize LifeScan Diabetes Testing Business in Chapter 11 Filing

Remember how back in 2017, Johnson & Johnson decided to exit the diabetes business? 

Johnson & Johnson began quietly exiting the diabetes business. First, it shut down Animas Corp., its insulin pump division, after failing to find a buyer. Then it sold Calibra Medical Inc., which had been developing a wearable insulin patch aimed at Type 2 diabetes insulin users, to CeQur. Finally, in 2018, J&J sold LifeScan — the maker of OneTouch meters and test strips — to Platinum Equity for $2.1 billion.

At the time, LifeScan was still the dominant player in traditional fingerstick blood glucose monitoring (BGM), with Roche and Bayer (now Ascensia) trailing behind. But the writing was on the wall: CGMs were gaining traction, and fingerstick testing was no longer a growth business.

Fast forward to 2025, and Platinum Equity's LifeScan business is in trouble. 

On July 7, 2025, Platinum Equity announced plans to reorganize LifeScan through a Chapter 11 bankruptcy filing https://www.bloomberg.com/news/articles/2025-07-14/platinum-backed-lifescan-in-talks-to-hand-control-to-lenders. That's behind a paywall, but a July 15, 2025 press release found at https://www.businesswire.com/news/home/20250715827575/en/LifeScan-Reaches-Milestone-Transaction-to-Improve-Financial-Flexibility-and-Enable-Future-Focused-Investments contains most of the same information.

The company's restructuring support agreement (RSA) had near-unanimous backing from first and second lien lenders, allowing Platinum Equity to retain control without investing another penny. But third lien lenders and more specifically Pharmacy Benefit Managers (PBMs) — who are owed $600–$700 million in rebates — are still negotiating (see https://9fin.com/insights/lifescan-deal-platinum-equity for more). According to Bondoro Insights (see https://bondoro.com/lifescan/ for details, view the chart under the heading "Top Unsecured Claims"), the big three PBMs are LifeScan's top three unsecured creditors, to whom LifeScan reportedly owes $244,689,400 to CVS Caremark, $234,926,000 to United Healthcare's OptumRx, and $196,301,600 to Cigna's Express Scripts which totals $675,917,000. The PBMs might end up with nothing.

Max Frumes of the firm known as 9fin who happens to oversee global coverage of what is referred to as "distressed debt and restructuring" described LifeScan's BGM business as a "melting ice cube," with declining revenues in developed markets. While CGMs dominate headlines, fingerstick testing isn't completely dead — it's just not growing anymore. For example, doctor's offices still rely on fingerstick readings for triage, not CGM data. I once got charged $55 for a test I could've done myself with my own meter and I have tested myself in my doctor's office to avoid those charges since that time!

Meanwhile, Roche — which once considered selling its own BGM business — held on and made a bold move (it did not really have a choice; no buyers with that much cash existed so they were unable to sell the business to anyone). In 2022, Roche partnered with Mark Cuban's Cost Plus Drug Company to offer Accu-Chek supplies directly to consumers (also see my own post on that HERE). That turned out to be a lucky move which was prompted by a heated discussion with patients back in 2009.

This bypassed PBMs and their legally-exempted rebate kickbacks, giving patients a cheaper option. I blogged about this shift https://blog.sstrumello.com/2025/05/cvs-caremarks-preferred-brand-switch.html in May 2025 when Aetna (via CVS Caremark) announced its plans to switch its preferred brand from OneTouch to Accu-Chek.

The irony? 

PBMs may now get nothing from LifeScan's unpaid rebates. Some lenders argue PBMs should be prioritized in bankruptcy because they're essential to the business — but I'm quite skeptical. PBMs are a money pit, and Roche's cash-pay model might be the smarter path forward. For example, Medicare no longer covers test strips for CGM users (which I covered HERE).

For those of us who attended Roche's 2009 social media summit, it's gratifying to see patient feedback lead to real changes — like redesigned test strip containers and more affordable pricing. My post from that event is still up at https://blog.sstrumello.com/2009/07/my-spin-on-roche-summit.html.

So what's next for LifeScan? 

It's a little late to the CGM game. Abbott and Dexcom dominate that space with Ascensia implantable version being an alternative, albeit not a widely-used alternative. For now, LifeScan's future hangs in the balance, and patients should keep an eye on how this restructuring plays out.

Could There Be Trouble In Civica's Insulin Biosimilar Paradise?

It is possible you might not have caught an obscure press release (see the press release at https://www.prnewswire.com/news-releases/biocon-biologics-and-civica-inc-collaborate-to-expand-insulin-aspart-access-in-the-united-states-302394010.html for more details) from March 6, 2025 released by Biocon Biologics Ltd. which had announced a deal with the U.S. nonprofit drug company Civica, Inc. for insulin aspart only. 

Under the terms of that particular agreement, Biocon Biologics agreed to supply insulin aspart drug substance to Civica, Inc., who will use that drug substance to produce its own insulin aspart drug product at its "fill & finish" manufacturing facility in Petersburg, Virginia (located near the state capital of Richmond). Civica will commercialize that medicine for patients in the United States, "after completion of development work and clinical trials". The latter's insulin Biologics License Applications (BLAs) are complete, except that Civica (as well as Biocon) awaits FDA approval decisions which have yet to be rendered as I write this. When Civica announced on March 3, 2022 that it was entering the U.S. biosimilars insulin space, the company revealed it would procure the insulin aspart Active Pharmaceutical Ingredient (API) from a firm known as GeneSys Biologics (see http://dlvr.it/SL0QZV for the original news release). Now, it has a new supplier, but [so far] only for insulin aspart.

In fact, while FDA finally approved Sanofi's biosimilar copy of insulin aspart on February 14, 2025 (catch my coverage of that at https://blog.sstrumello.com/2025/02/fda-approves-merilog-insulin-aspart.html for more), becoming the first biosimilar insulin FDA rendered a decision on in over three years, that lead me to question the reason FDA has a substantial backlog of insulin biosimilars which it has not yet rendered decisions on (see https://blog.sstrumello.com/2025/01/ask-fda-why-arent-insulin-biosimilars.html for my coverage of that). 

Let me add that we are now more than halfway through 2025, and FDA has approved only one insulin biosimilar, and yet we know at least ten others are pending from Sandoz/Gan & Lee, Lannett Company/HEC, Amphastar Pharmaceuticals/ANP as well as Civica and whomever the company procures the insulin APIs from. Those include more biosimilars of glargine, aspart and a few of lispro. And, we know another three more are a few years behind those, including three from Meitheal Pharmaceuticals/THDB (which has copies of glargine, aspart and lispro in development). Originally, I presumed some of the delays were attributed to worldwide Covid-19 lockdowns, but there are hints of more problems at FDA and potentially with some of the companies developing insulin biosimilars more broadly. 

The reason the March 6, 2025 news release from Biocon and Civica on insulin aspart was so surprising is because when Civica first announced that it intended to sell biosimilars of insulin glargine, insulin aspart and insulin lispro (to be sold at a price of no more than $30/vial or $55/box of five prefilled insulin pens), is because when Civica (along with Breakthrough T1D/JDRF) made the original announcement about three years earlier (back on March 3, 2022) that Civica would be entering the biosimilar insulin business, Civica revealed that it would procure the insulin Active Pharmaceutical Ingredients for each from a Hyderabad, India-based biotechnology firm known as GeneSys Biologics, Ltd., but not from Biocon. One additional peculiarity is that the March 6, 2025 announcement was the agreement was only for insulin aspart, but not for the insulin glargine or for insulin lispro biosimilars. 

The original 2022 Civica press release stated: "Civica has entered into co-development and commercial agreement with GeneSys Biologics for these three insulin biosimilars." You may read the company 2022 press release at https://www.businesswire.com/news/home/20220303005321/en/Civica-to-Manufacture-and-Distribute-Affordable-Insulin/ along with the concurrent JDRF (now Breakthrough T1D) press release at https://www.prnewswire.com/news-releases/jdrf-announces-support-of-civica-to-manufacture-and-distribute-low-cost-insulin-301495050.html, although I covered news about the 2022 announcement on my blog in a post found at https://blog.sstrumello.com/2022/03/civica-rx-were-entering-us-insulin.html for more details. Originally, I presumed FDA had a slight backlog which might be attributed to worldwide Covid-19 lockdowns, but I think because FDA collects user-fees from these companies, it has an obligation to render decisions (which it has not yet made), and it can use the user-fees which it collects to pay for the staff needed to make those decisions. 

There is something else peculiar about the 2025 Biocon Biologics/Civica announcement on insulin aspart. On January 7, 2022, Biocon Biologics revealed to investors that the U.S. FDA had denied the company's insulin aspart application by issuing a Complete Response Letter (CRL). However, Biocon told investors "This CRL did not identify scientific issues with the product but referenced Form 483 observations (which are Inspectional Observations at the conclusion of a manufacturing facility inspection. It lists conditions or practices observed during the inspection that, in the investigator's judgment, may constitute violations of the Food, Drug, and Cosmetic Act or other relevant FDA regulations.) from a pre-approval inspection of their [Johor,] Malaysia facility." (see https://www.bioconbiologics.com/the-usfda-issues-a-complete-response-letter-for-the-biologics-license-application-bla-for-insulin-aspart/ for more). Still, in the three years since then, FDA did not move on any insulin biosimilars until its Valentine's Day approval of Sanofi's Merilog biosimilar of Novo Nordisk's Novolog. Three years, user fees, and no decisions? That strikes me as pushing the limits on decisions. Its not as if taxpayers are paying for the staff needed to make these decisions, the applicants are paying for that. 

What this means is that effective as of March 6, 2025, Civica announced a new supply agreement for a Novolog biosimilar from a company which does not even have FDA approval to sell an insulin aspart biosimilar. But this could suggest that the biotech partner Civica originally announced an agreement with back in March 2022 known as GeneSys Biologics might be having some issues in replicating the insulin aspart molecule, effectively prompting the company to find a new supplier for that, and the supplier the company chose is Biocon Biologics (which does not yet have FDA approval to sell an insulin aspart biosimilar). 

We should be asking whether Civica might have observed problems with GeneSys Biologics making copies of Novolog specifically, and sought to resolve that with a more experienced partner who had the ability to deliver. Remember: Biocon's aspart biosimilar was denied by FDA not for scientific reasons, but because previous citations by FDA at its Johor, Malaysia manufacturing facility had not yet been resolved. FDA won't approve any others until existing problems are fixed to its satisfaction. 

So far, we have not yet heard any particular problems on copies of Lantus or Humalog, although if the partner cannot deliver on them all, that is not very reassuring. And, Civica might remain committed to its original contract with GeneSys Biologics on glargine and lispro suggesting that the main difficulties were with aspart.

Maybe. But there is a sense in the biotechnology industry that making copies of insulin analogues might be easier than it really is. That's where having a competent biotech partner can help, and also a partner which can manage those relationships. 

Sandoz has a Chinese lab partner named Gan & Lee making its insulin biosimilars (catch some of my prior coverage HERE and HERE), and in 2023, Gan & Lee has regularly reported via LinkedIn when the company had submitted BLA's (Biologics License Applications) for glargine https://www.ganlee.com/detail/683.html, lispro https://www.ganlee.com/detail/690.html, and insulin aspart https://www.ganlee.com/detail/691.html. My impression is that even while Gan & Lee is based in China, Sandoz is managing its partners' development timeframes and milestones quite closely. And yet, FDA hasn't (yet) rendered any decisions on those, either. 

We should demand that our lawmakers ensure the FDA makes some decisions. Covid is over, so excuses for not rendering those decisions is unacceptable and they have had several years to consider them.

Mark Cuban Cost Plus Drug Company Enters the Telehealth Arena for Generic GLP-1s

On June 17, 2025, Mark Cuban Cost Plus Drug Company PBC announced a collaboration with a telehealth company known as 9amHealth (see the press release at https://www.prnewswire.com/news-releases/mark-cuban-cost-plus-drug-company-pbc-and-9amhealth-join-forces-to-expand-access-to-affordable-obesity-care-302482628.html, and one article at https://www.fiercehealthcare.com/payers/mark-cubans-cost-plus-drugs-partners-virtual-obesity-clinic for more details). It is worth acknowledging that 9amHealth is a startup begun Frank Westermann and Anton Kittelberger, and as FierceHealthcare documented, both of those guys happen live with Type 1 diabetes themselves even though their business is primarily focused on T2D and obesity [9amHealth is also the telehealth company which Lilly's LillyDirect uses]. 9amHealth's services are anything but cheap; membership costs $149 per month, which is why the Mark Cuban Cost Plus Drug Company/9amHealth telehealth collaboration will initially focus on employers.

You may recall that STAT News reported back in October 2024 (the article is behind a paywall, but if you have access, visit https://www.statnews.com/2024/10/17/telehealth-online-compounded-glp1-prescriptions-medical-groups/ for more) that "sketchy" telehealth firms were responsible for a vast majority of the GLP-1 prescriptions. Not surprisingly, all of those prescriptions have been for the newest, most expensive GLP-1 products, never for less costly generic products (as I write this, the U.S. Food and Drug Administration [FDA] has approved three generic GLP-1 medicines, all of which are for the drug known generically as liraglutide [fka Victoza/Saxenda]). You may also recall that I blogged that researchers from Cedars-Sinai Medical Center in Los Angeles showed an overwhelming majority of those GLP-1 prescriptions were for weight-loss instead of for Type 2 diabetes. Regardless, being denied access to less-costly GLP-1s whether for T2D or obesity is an issue, which is why the Mark Cuban Cost Plus Drug Company PBC/9amHealth could potentially be disruptive.

Teva Pharmaceuticals introduced the first generic GLP-1 on June 24, 2024 (I blogged about that at https://blog.sstrumello.com/2024/07/tevas-biosimilar-of-liraglutide-will-be.html). However, I discovered that most of the same companies which are working on bringing biosimilar insulins to market all also have generic versions of liraglutide pending approval decisions. Teva's copy of Victoza was followed by another copy from Hikma Pharmaceuticals USA, which was approved on December 23, 2024 and then another copy from Meitheal Pharmaceuticals on April 3, 2025 (catch my coverage of those at https://blog.sstrumello.com/2024/12/fda-approves-second-generic-glp-1.html for more). More copies of liraglutide from Biocon, Sandoz, Amphastar Pharmaceuticals, and Lannett Company are known to be in development.

There are a few items worth pointing out. 

First, these are hardly the only generics, these are merely the first ones to receive FDA approvals. But a bunch more copies now await approval decisions, and with each new generic to hit the market, prices tend to fall even further. The initial discounts were modest at best, so the more that come to market, the more prices are expected to fall.

Second, it is worth acknowledging that the first three copies of liraglutide are currently only approved for the treatment of Type 2 diabetes (fka Victoza). Just as Novo Nordisk did originally, the generics companies will need to successfully apply for an FDA "label extension" for the indication of obesity without Type 2 diabetes (fka Saxenda). Those label extensions have not yet happened, but are widely expected to happen. That's when the real gold-rush on less costly generic products is anticipated to start.

Nevertheless, the Mark Cuban Cost Plus Drug Company/9amHealth collaboration is a new dynamic which should likely send shivers down the spines of executives working in Bagsværd, Denmark where Novo Nordisk is headquartered. The reason is because a generic GLP-1 suddenly has a telehealth entity which can prescribe the generic product as freely as the overpriced branded drugs do, opening access to a much wider audience. That dynamic was assuredly never in Novo Nordisk's business plan.

You might also recall that Novo Nordisk's CEO Lars Fruergaard Jørgensen was recently asked to step down (he was essentially fired, although the company Board of Directors instead asked for him to comply with their request that he leaves, or else they would terminate his employment for him, see https://www.fiercepharma.com/pharma/novo-part-ways-longtime-ceo-lars-fruergaard-jorgensen-citing-weight-market-pressures for more). Although the articles on Jørgensen's termination cited competitive pressures in the obesity drug market, that really wasn't the whole story at all.

Novo Nordisk is currently paying big Pharmacy Benefit Managers (PBMs) billions of dollars for "formulary exclusion" of all competing GLP-1 products, which also includes cheaper generics. 

Ironically, it was because of magnitude of Novo Nordisk's U.S. rebating practices to PBMs for insulin that Mr. Jørgensen's predecessor named Lars Rebien Sørensen, who "retired" in 2016, leaving behind shareholder litigation over the magnitude of the company's exposure to legally-exempted rebate kickbacks paid for "formulary exclusion" of all competing insulin products that Lars Fruergaard Jørgensen even became CEO of the company (his predecessor was pushed out of the job, too, which should have been a warning which he ignored). 

It was under the leadership of Lars Fruergaard Jørgensen that Novo Nordisk quietly settled that shareholder lawsuit out-of-court without admission of any wrongdoing (see https://www.bloomberg.com/news/articles/2017-04-28/novo-nordisk-is-sued-over-diabetes-drug-sales-practices for more). Sadly, Mr. Sørensen's successor Mr. Jørgensen not only doubled-down on those kickbacks, but he actually accelerated them, except the bribes were no longer being paid on the insulin therapeutic class of drugs, but on GLP-1s instead (as if that made the practice any different?).

Perhaps it's not at all surprising that Lars Fruergaard Jørgensen got himself fired. He repeated the same ethically-challenged business practices as his predecessor, while he also accelerated those practices. But this post is not about the weakness of Novo Nordisk corporate executives or their lack of ethics. Instead, it is about a marketplace disruptor known as Mark Cuban and his Cost Plus Drug Company deploying the very tactic which sent Wegovy/Ozempic U.S. sales through the roof: telehealth prescribers and suddenly the ability to do this for a cheaper generic product. I've addressed Mark Cuban Cost Plus Drug Company as a disruptive force in the pharmaceutical industry in several previous posts, including the following:

• https://blog.sstrumello.com/2022/10/podcast-recommendation-global-healthy_21.html,
• https://blog.sstrumello.com/2022/10/podcast-episde-recommendation-twist.html,
• https://blog.sstrumello.com/2023/02/mark-cuban-cost-plus-drug-company.html,
• https://blog.sstrumello.com/2023/04/podcast-episode-recommendation-pulse-by.html, 
• https://blog.sstrumello.com/2025/03/sanofi-gets-creative-now-that-pbm.html, 
• https://blog.sstrumello.com/2025/05/cvs-caremarks-preferred-brand-switch.html

While Mark Cuban Cost Plus Drug Company has partnered with a telehealth company of its own and will target employer organizations as a way for them to slash their costs on GLP-1s as obesity drugs, there is now little which would stop an enterprising company from establishing a mail-order business to sell less costly versions of Saxenda. But telehealth is a key to making it happen. 

That also means that unlawful compounders of newer GLP-1s such as semaglutide (Ozempic/Wegovy) which have witnessed Novo Nordisk terminating relationships with companies such as Hims & Hers Health, Inc. (see HERE for more) might instead consider selling legitimate generics of the GLP-1 known as liraglutide, although it might wait until one of them receives an FDA label-extension for the indication of obesity which is widely expected to happen rather soon. Just imagine a company like Hims & Hers pushing generics of Saxenda!

That ought to make executives in Bagsværd justifiably nervous (and deservedly so). 

CMS Medicare No Longer Covering Fingerstick Test Strips for CGM Users, But Policy Can (and Should) Be Rescinded

Integrated Diabetes Services (IDS), which if you're unfamiliar with it, is an organization dedicated to coaching and management services for people with diabetes (either in-person in its suburban Philadelphia office in the Main Line town of Wynnewood, or remotely via phone or the internet, was started by CDE Gary Scheiner. Gary has been one of the most recognized CDE's in the country for many years. Anyway, his organization recently published on a blog post entitled "'Buy-Buy' Test Strips for CGM Users" which I encourage you to read at https://integrateddiabetes.com/cms-has-stopped-covering-meters-strips-for-cgm-users/ which addressed how CMS (the Centers for Medicare and Medicaid Services, which runs Medicare and also helps states implement Medicaid), on May 13, 2022 proposed a policy (see https://www.cms.gov/files/document/cms-1738-r.pdf) whereby Medicare will no longer be covering traditional fingerstick blood glucose testing supplies (strips) for Continuous Glucose Monitor (CGM) users. The thing is that CMS never announced this policy change in the Federal Register. Regardless, that policy is now in effect. But what it portends for those covered by commercial health insurance policies is what we need to beware of.

Medicare already had fairly miserly coverage of traditional test strips, but at least they previously covered them for CGM users. Now, CMS has rescinded a previous decision to cover them. Effective as of January 1, 2025, CMS (the organization that administers Medicare and Medicaid) ruled that all users of FDA-approved CGM devices classified as "non-adjunctive" (not requiring fingerstick confirmation) were not eligible for coverage of fingerstick Blood Glucose (BG) monitors and test strips.

The thing is that this is not exactly what the U.S. Food and Drug Administration has determined for CGMs. Technically, CGMs are not designed to replace fingerstick testing outside of a hospital setting. That means that FDA still believes fingerstick tests are required for CGM users unless the patient is checked-in to a hospital where there are nurses around who can treat patients for hypoglycemia if the patient is unable treat a low for themself. Specifically, FDA determined that "Non-adjunctive CGM usage was for in-hospital sites, allowing BG levels to be monitored from a central nurses' station backed up with ancillary resources." However, "out-of-hospital sites usually lack ancillary resources except EMT vehicles.  Ancillary resources represent 'proven workarounds'". 

But more troubling (at least to me) aspect of this was the following observation IDS made about what this CMS determination will likely mean for patients who are covered by commercial healthcare insurance plans. Specifically, in the fourth paragraph, IDS wrote:

"This ruling most likely will be promulgated to all health plans."

This should terrify people. As IDS opens its article: 

T1D is a numbers game. Run out of numbers, and the game is over. Diabetes, by its very nature, is an ever-changing condition, honed through experimentation – much like parachuting. Jumping with a failed main chute and no functional reserve chute is unlikely to produce anything good.

Not only is Medicare not covering strips for people who arguably need coverage of at least some test strips, but this will be a convenient excuse for people covered by employer-sponsored healthcare insurance plans to stop covering test strips for patients who use CGMs as well.

Now, while the CMS policy is already now in place (unless that failed policy is rescinded, which it should be) it has not (yet) been adopted by commercial healthcare insurance plans, but it is safe to assume that it will be as soon as United Healthcare, Cigna and Aetna can do so. That is, unless we intervene. And we must!

IDS recommends that you immediately contact your Congressman/woman and both of your Senators to withdraw this errant policy issue, cancel, correct, revise [or burn] this CMS ruling 1738-r in order to restore Blood Glucose Meter (BGM) coverage and test strips when using a non-adjunctive CGM for out-of-hospital settings so we can all rest easier at 03:00 AM.

In the interim, for anyone adversely impacted by this CMS policy, my recommendation is as follows. Since November 14, 2022, Mark Cuban Cost Plus Drug Company has sold Roche Accu-Chek testing supplies at cost plus a markup of 15% and a distribution fee. I blogged about how my insurance company recently notified me it was switching to Accu-Chek as its "preferred" test strip brand in a recent blog post found at https://blog.sstrumello.com/2025/05/cvs-caremarks-preferred-brand-switch.html. I also blogged about how I recommend people choose the Accu-Chek "Guide" meter which is slightly more expensive than the "Guide Me" meter, but features a lighted test strip port and backlit display instead of guidance of what the meter readings might mean (which is far more helpful for newly-diagnosed patients) rather than a lighted test strip port, which I find more helpful.

The Mark Cuban Cost Plus Drug Company cost for a package of 50 test strips is currently $18.79, or $0.38 per test strip. That's not the least costly price for test strips which can be found anywhere, but it's also not excessively overpriced as retail prices for testing supplies often are; rather it is a fair price for branded test strips. Those prices are available via its mail-order (and there is no maximum quantity even while the website has a maximum of 3 vials of 50 strips, if you doctor prescribes more for you, they will mail you more. Also, know about something called the Team Cuban Card which enables patients to visit local pharmacies affiliated with Mark Cuban Cost Plus Drug Company (most are based in big supermarket chains which still operate pharmacies in-store). That's an option where you can take a printed prescription in-store and pick the supplies up at a local pharmacy and receive the Mark Cuban Cost Plus Drug Company price.

CVS Caremark's Preferred Brand Switch from OneTouch to Accu-Chek in 2025

I recently received notice from Aetna (the insurance company which is owned by CVS Health) that on July 1, 2025, its Pharmacy Benefit Manager (PBM) known as CVS Caremark was making some changes to the drugs covered under its pharmacy benefits plan (specifically for the formulary known as Advanced Control Plan-Aetna). However, because I live in New York State, it also means those drug coverage changes will not affect me personally until my plan's actual renewal date, which is on June 1, 2026. By that time, my insurance carrier may have changed anyway. 

CVS Caremark lost its rein as the biggest PBM to rival Cigna's Express Scripts this year. The reason is because in 2025, CVS Caremark lost Centene as a major insurance client (to Cigna's Express Scripts). That loss contributed to Express Scripts (see https://www.drugchannels.net/2025/03/the-top-pharmacy-benefit-managers-of.html for more on that market-share switch among PBMs) overtaking Caremark in PBM market share (it doesn't take much to change rankings given how consolidated the PBM industry is). 

For me, the most notable among the changes in the Advanced Control Plan-Aetna formulary is that OneTouch-branded blood glucose testing supplies (including either Verio or Ultra test strips; the Lifescan business selling the OneTouch brand of testing supplies has been owned by the private equity firm known as Platinum Equity since 2018) are being reclassified by Caremark as "Non-formulary; not covered" and instead, Caremark will instead "prefer" Roche Accu-Chek testing supplies instead. This is not the first time Aetna/CVS Caremark has "preferred" Accu-Chek blood glucose testing supplies; that was also true in 2021 when I was also covered by Aetna. But over the years, I've been regularly non-medically switched by PBMs to different brands of testing supplies, as well as different brands of insulin. Insulin changes are a major pain in the @$$, but testing supply changes are less of a hassle. As a result, the switches have been less intrusive as they once were as I already have meters for all the major brands. All I need is fresh batteries for the old meter, and voila: I'm ready.

But one other element which is worth acknowledging is that on November 14, 2022, as part of a partnership with Roche Diabetes Care (see the announcement at https://www.accu-chek.com/news/roche-and-mark-cuban-cost-plus-drug-company-team-deliver-affordable-access-diabetes-testing for details), the Mark Cuban Cost Plus Drug Company started carrying Accu-Chek diabetes testing supplies. Most of Mark Cuban Cost Plus Drug Company's major pharmacy retailers in its network are with supermarket chains which still operate pharmacies in-store (and there happens to be one which is not really too far away from me, although I am also OK with mail order to acquire testing supplies, just not so much on insulin; as insulin shipments are sometimes known to sit in very hot 100+ degree or literally freezing warehouses for several days and those extreme temperatures can literally destroy insulin). The Cost Plus Drug Company partnership also means I'll be able to use preferred formulary brand products, but I'll be able to buy them for cash for much less money until my deductible has been satisfied.

I have also discovered that even when PBMs switch their "preferred" brands but there are some unique state law exemptions (as is my case), although the PBM is often more-than-happy if a patient actually switches to the PBM's new "preferred" brands. On test strips, it really does not really matter very much to me, and Roche Accu-Chek has a few different meters (along with test strips for each) which would be covered, but my preference is to use the Accu-Chek "Guide" system (as opposed to the default "Guide Me" meter which costs the PBM about half as much money) because the "Guide" meter features a lighted test strip port & backlit display, making it more convenient to test in low-light situations, and the screen which shows the reading is illuminated.

Of course, the cases for the Accu-Chek "Guide" meter are made of flimsy nylon, but they are also small that they take-up considerably less space in the bag I carry around. On the upside: one nice thing is the package for Accu-Chek Guide test strips is easier for patients to remove test strips from the package they come in, so that's a plus. That was the result of a conversation Roche had with patients (including me) with the company back in 2009 (catch my coverage of that at https://blog.sstrumello.com/2009/07/my-spin-on-roche-summit.html). I never thought much would come from those conversations, and yet this is a concrete example that the company actually listened to patients at the event!

Another thing which occurred at the Roche-patient meetings was the realization among company executives that the rebate-contracting sales model promoted by the big PBMs was actually harming patients. Apparently, that realization led to the aforementioned Roche-Mark Cuban Cost Plus Drug Company initiative.

Of course, the consolidated commercial healthcare insurance companies and the PBMs they own and operate are doing their own thing, often at the expense of patients, for example, in its most recent announcement, CVS Caremark reclassified many generic drugs as "specialty" pharmaceuticals when there is nothing which is special about those cheap generic drugs. The U.S. Federal Trade Commission Second Interim Report on PBM Business Practices documented that sleazy PBM practice. The good news is that for some of those drugs, patients can easily buy them for cash at prices which are more than 1000% LESS than CVS Caremark's Specialty Pharmacy charges. A great example is the prostate cancer drug known as Abiraterone Acetate (the generic for Zytiga). A report by HealthUnlocked cited one patient's experience where their insurance was charged $9,650 per month for generic Abiraterone Acetate through CVS Caremark's "Specialty" Pharmacy. Not ironically, that same drug also happens to be the first drug ever sold by Civica (the same company working on bringing biosmilar insulins to market). By comparison, Mark Cuban Cost Plus Drug Company charges just $51 for the exact same medication (Abiraterone Acetate). The FTC is now suing CVS Health (as well as United Healthcare-OptumRx and Cigna-Evernorth/Express Scripts) over these corrupt business practices, although as I documented, the case is currently "on hold" until there is a quorum of judges who can rule on the case.

Note that the outer package of Accu-Chek test strips sold by Mark Cuban Cost Plus Drug Company says "Not for Pharmacy Benefit or Over-the-Counter Transactions" in a yellow box at the bottom. The outer box has changed color recently but the contents are no different (on the label which says "Not for Pharmacy Benefit or Over-the-Counter Transactions," my response is: "who cares?"): 

 

For me, the change in the PBM's preferred test strip brand is a minor inconvenience. Because I have struggled to get a prior authorization for a larger quantity of test strips for longer than 6 months with Aetna (less of a hassle with United Healthcare and Cigna), I have already been bypassing insurance to buy Accu-Chek testing supplies anyway. But such routine non-medical switching has become an annoyance. Fortunately, I've dealt with it previously and know the game better than CVS Caremark at this point.

My Prediction About Abbott Libre FORCING Dexcom to Introduce a Longer-Wearing CGM Sensor Was Right

It's nice when my predictions prove correct. One example: following the ADA 84th Scientific Sessions in 2024, I made a prediction (see https://blog.sstrumello.com/2024/07/abbotts-freestyle-libre-3-plus-may-push.html for more on my prediction) that Abbott's move to increase wear-time on its sensors would force Dexcom to respond with a longer-wearing CGM sensor of its own, and that's now happened. 

I surmised that based on the fact that Abbott (which makes the Freestyle Libre CGM system) introduced a longer-wearing FreeStyle Libre 3 Plus which lasts for 15 days (as opposed to only 14 days on Libre 3 sensor), substantiated by hints from Dexcom CEO Kevin Sayer that Dexcom was working towards a longer-wearing G7 sensor, although he cited issues with the adhesive lasting long enough to ensure its 15-day G7 Plus sensor lasts its entire useful life as the reason for not doing so when the G7 launched. However, remember that Dexcom's G7 and Stelo use the exact same CGM sensor, only the wear-time for Stelo was already 15 days versus a mere 10 days for the regular Dexcom G7, hence I was calling Kevin Sayer out for a misleading statement. It had more to do with milking as much cash out of the shorter 10-day G7 sensors for the financial benefit of Dexcom shareholders. But the competition from Abbott eventually forced Dexcom to respond with a longer-wearing sensor of its own.

Last week [on April 10, 2025], Dexcom announced it received FDA approval (see the press release at https://www.businesswire.com/news/home/20250410304660/en/Dexcom-G7-15-Day-Receives-FDA-Clearance-the-Longest-Lasting-Wearable-and-Most-Accurate-CGM-System) for a new, longer-lasting Dexcom G7 15 Day sensor. The consensus among patients I have spoken with is that longer wear-time was the least Dexcom could do for patients given how erroneous the first day of each Dexcom G7 sensors actually are. Many are still concerned about the longevity of the sensor adhesive (Skin-Tac adhesive, anyone?) and the fact that Dexcom weighs more than Libre so the sensors are less likely to last for the full 15 days than Abbott Libre 3 Plus sensors are to last is also an issue.

To be sure, the Dexcom G7 15 Day sensor is still no longer than Abbott's Freestyle Libre 3 Plus sensor. But it is an improvement of the longevity on Dexcom's regular G7 CGM sensor which has a miserly 10-day wear-time. As for the accuracy claims made in Dexcom's G7 Plus press release, those are bogus, or at best, misleading.

MARD (the acronym for Mean Absolute Relative Difference) is a widely used metric for CGM accuracy, but its lack of standardization has led to significant concerns. The primary critique revolves around the fact that different CGM manufacturers calculate MARD using varying [different] methodologies, making direct comparisons of accuracy between CGM devices unreliable at best.

Some key issues include:

• Variability in Reference Measurements: Manufacturers may use different reference glucose measurements (e.g., venous plasma, capillary blood, or laboratory-calibrated values), which can affect the reported MARD.
  
  
• Differences in Time Matching: The timing of CGM readings compared to reference values can vary, leading to inconsistencies in accuracy assessments.
  
  
• Data Selection Bias: Some manufacturers may exclude outlier data or use specific subsets of readings to improve their reported MARD, making it appear more favorable than it would be in real-world conditions.
  
  
• Lack of Regulatory Standardization: Since the FDA does not enforce a universal calculation method, manufacturers have flexibility in how they report MARD, leading to discrepancies in accuracy claims.

For more background on the critical assessments of Mean Absolute Relative Difference (MARD) as it is currently used by the U.S. Food and Drug Administration, please refer to:

• https://diabetesjournals.org/care/article/46/10/1825/153465/Real-world-Accuracy-of-CGM-in-Inpatient-Critical 
  
  
• https://diabetesjournals.org/spectrum/article/35/4/405/147875/The-Devil-Is-in-the-Details-Use-Limitations-as 
  
  
• https://diabetesjournals.org/care/article/48/2/259/157542/Continuous-Glucose-Monitor-Accuracy-for-Diabetes 

The critique has led to some calls for more standardized accuracy metrics, such as the Clarke Error Grid or Consensus Error Grid, which might provide a more clinically relevant assessment of CGM performance over MARD.

Anyway, on price, Dexcom's 15-day G7 sensor means patient out-of-pocket costs will be coming down. Given erroneous first day readings many patients experience on the G7, in reality, the longer-wearing sensor gives patients more like 14 days of sensor usage rather than 15 days.

Still, it's nice when my predictions are proven correct, as mine was when Abbott introduced a longer-wearing CGM sensor, which forced competitor Dexcom to match it. Patients may still prefer Abbott's Libre 3 Plus over Dexcom's G7 Plus. Not only is Abbott Freestyle Libre 3 Plus smaller in size than Dexcom G7 Plus, but Libre 3 Plus provides 1440 new readings each day compared to a mere 288 new readings with Dexcom G7 Plus. The one downside with Libre is no calibrations although Dexcom pretty much ignores the calibrations anyway. Better to have more readings IMHO. With manufacturer coupons (which I covered at https://blog.sstrumello.com/2023/12/abbott-gets-real-about-formulary.html for more information) means that it really does come down to patient preference for which CGM better meets their needs.

Increasingly, many patients are choosing Abbott rather than Dexcom to due Abbott Libre's unique product advantages. That, combined with third-party apps enabling Libre 3 Plus readings such as Sweet Dreams – Sugar Tracker on Apple Watch (see my coverage at https://blog.sstrumello.com/2024/05/get-abbott-freestyle-libre-3-readings.html for more about that) means that Dexcom's longstanding market dominance does not look so well-protected anymore. 

Stocking Up On Artificially-Inflated Diabetes Supplies Ahead of Travel in 2025

In 2025, I will be traveling to East Asia (separately, I'm also going to Europe for a shorter visit at a different time in 2025) for a few weeks. Because it is going to be an extended visit so far from home, that will necessitate me packing a lot of diabetes supplies to take with me. To ensure that I have the diabetes supplies for the duration of my trip, that requires some advance planning. But I don't expect my insurance company's Pharmacy Benefit Manager (PBM) to be helpful at all.

The good news is that insulin will be the easy part, and the reason is because all of the big insulin makers have effectively abandoned the rebate-contracting sales model for insulin, meaning U.S. list prices for insulins are falling (after rising inexplicably for more than a decade) quite unlike most other prescription drug classes. While purchase quantity limits represents a potential problem, I plan to ask my endocrinologist to write me another script (or two), and I can then fill those scripts at different pharmacies and use manufacturer coupons, hence the quantity limit ordinarily imposed by my insurance company's PBM might not represent a problem I might have encountered in the recent past.

Dexcom first began selling its products through U.S. retail pharmacies back in 2018, and it expanded its sales via the pharmacy (as opposed to Durable Medical Equipment or "DME") sales channel until most of its sales were made via retail pharmacies which occurred around 2020. Along with that, the company also began paying the big PBMs legally-exempt rebate kickbacks which were contingent upon "formulary-exclusion" of any and all competing CGMs sold via retail pharmacies (which essentially means that Dexcom is the "preferred" CGM brand, while Abbott's Freestyle Libre CGM systems are explicitly excluded from Aetna and United Healthcare preferred drug formularies, which are managed by the PBMs known as Caremark and OptumRx respectively). But I think I have found an effective work-around for that and I intend to use that to bypass insurance to stock up on diabetes supplies.

Aside from insulin, here's my plan to stock-up on Dexcom G6 CGMs.

Dexcom has a manufacturer coupon (for the G6/G7 model, it can be accessed at https://www.dexcom.com/savings-center-cgm-without-insurance where a coupon to save up to $200/month on both G6 sensors and G6 transmitters. The coupon can be downloaded at https://dexcompdf.s3.us-west-2.amazonaws.com/g7-g6-cash-pay-tearpad.pdf. Of course, finding the lowest price on Dexcom G6 sensors (and transmitters) also still matters, because the lower the retail price for sensor, the lower the patients' out-of-pocket costs will be. And I have found that Costco Pharmacy appears to have some of the most competitive prices on Dexcom G6 sensors (and transmitters). Costco Pharmacy has an online tool to check prescription prices online which can be found at https://www.costco.com/cmpp and that tool is helpful to understand the cash prices for many prescriptions (including CGM sensors).

Costco's Member Prescription Program ("CMPP") price for Dexcom G6 Sensor (1 box containing 3 sensors in each box) is (as I write this) currently priced at $195.19 which works out to a price of $65.06 for each Dexcom G6 sensor. Once a prescription has been filled at Costco's in-store pharmacy, patients do have the option to refill their prescriptions by using Costco's Rx Home Delivery service which saves the patient the time-consuming hassle of driving to Costco and finding a parking space for routine prescription refills. Costco's Rx Home Delivery service charges an additional $2 for shipping/handling over the in-store price for filling a script at the in-store pharmacy, hence the cost for a box of three G6 sensors by Costco Rx Home Delivery would be $197.19 which works out to a price $65.73 for each G6 sensor. But that spares the patient the hassle of going into a crowded Costco location, finding a parking space and waiting in a long queue.

By comparison, rival CGM manufacturer Abbott also has a cash-pay manufacturer coupon as well. I blogged about that at https://blog.sstrumello.com/2023/12/abbott-gets-real-about-formulary.html. The Freestyle Libre 3 sensors are sold individually at a price of $68.32/sensor, or marginally more costly than Dexcom's price of around $65.73/sensor, but the real differential is how long can each CGM sensor be worn? That is where Abbott's Freestyle Libre 3 is vastly cheaper because those sensors can be worn for 14 days compared to just 10 days for each Dexcom G6 sensor. That means the cost per day of usage is $6.73 with Dexcom G6, while it is just $4.88 per day of usage on Libre 3 due to Libre's longer wear-time. And, don't overlook the not-so-little fact that the newer Libre 3 Plus can be worn for 15 days, which effectively cut prices on CGM sensors even further. So far, I do not see the Libre 3 Plus prices at Costco listed right now.

But remember how I mentioned that Dexcom offers a manufacturer coupon for up to $200/month for sensors and transmitters on the G6 model? That means I can get the CGM sensors covered for next to nothing [ideally], but certainly no more than I would pay with insurance. Which is weird. It means in addition to the sensors which my own insurance company's PBM is covering (at least partially; my plan covers about 37% of the cost prior to me having satisfied my annual deductible). In other words, I can keep using my Dexcom G6 sensors using my insurance at one pharmacy, while concurrently buying G6 sensors at Costco Pharmacy using a manufacturer coupon to pack with me on my upcoming trip to Asia.

For me, the only wildcard will be fingerstick blood glucose test strips. I have bought Accu-Chek Guide test strips from Mark Cuban Cost Plus Drugs for $18.79 per box of 50 test strips which is not too bad. I filled one script at Cost Plus Drugs last year, but did not fill it again because I had already satisfied my deductible and insurance picked up the tab after that. However, that is not necessarily the lowest price I've ever seen for test strips. My old OneTouch Ultra meter is still working, and I have bought generic UniStrip1 test strips for that meter which can be purchased for an even lower price, so we'll see what I decide to do on those.  

Sanofi Gets Creative Now That the PBM Kickback Scheme for Insulin is Dead

Look for Sanofi Insulins at Mark Cuban Cost Plus Drug Company Retail Store Partners Soon

Sanofi Aventis LLC, which is the U.S. division of the global pharmaceutical company Sanofi S.A. which happens to be headquartered in France and sells several insulin varieties in the U.S., has struggled to compete in the U.S. insulin business. For many years, Lantus was generating an overwhelming majority of the company's insulin revenues with its other products generating little sales in the U.S. That was the result of a very conscious business decision which the company had made more than 20 years ago. Now, Sanofi may be reconsidering that flawed decision.

Recall that back on March 4, 2020, on the front page of the Marketplace section of the Wall Street Journal, Sanofi cried to reporter Denise Roland that the realized price it received for its insulin had fallen, on average just over 11% in 2019, including the massive legally-exempt "rebate" kickbacks which it pays to insurers and their Pharmacy Benefit Managers (PBMs) for formulary placement (for reference see "Sanofi, Fighting Back in Insulin Price Debate, Says Its Net Prices Fell 11%" By Denise Roland, Wall Street Journal, March 4, 2020, https://www.wsj.com/articles/sanofi-fighting-back-in-insulin-price-debate-says-its-net-prices-fell-11-11583340721 [the article may be hidden behind a paywall]). However, at the time, Sanofi had effectively abandoned all marketing of prandial insulins including its proprietary rapid-acting Apidra product which received FDA approval in 2004, plus Sanofi's copy of Lilly's Humalog insulin lispro product which it had branded as Admelog. 

Sanofi's Lantus sales addiction was so major that in 2015, Sanofi introduced a very high concentration version of glargine in 300 units/mL potency which it branded as Toujeo; a product which was aimed primarily at patients with clinical insulin resistant Type 2 diabetes. However, to its credit, Sanofi did give the high-potency version a unique trade-name which I think does a better job of minimizing risk of pharmacy and patient errors. The same is NOT true for Novo Nordisk's Tresiba, or Lilly's Humalog, which have been quietly introducing high-concentration versions (U-200 and U-300) under the same brand names.

In other words, Sanofi had really put all of its eggs in the Lantus/Toujeo insulin basket. In fact, one could argue that Sanofi only introduced Admelog in the U.S. as retribution against Lilly for introducing Basaglar a year earlier (Basaglar was Lilly's first copy of Sanofi's Lantus which was approved in 2016 as a "follow-on" biologic; Lilly subsequently introduced a second copy of Lantus it calls Rezvoglar which was approved by FDA in 2022 as a biosimilar, which then went on to attain the FDA "interchangeable" designation on November 18, 2022). In spite of an early, promising start to Admelog sales (which was enabled largely by the company's $35/vial manufacturer coupons which remain available, although Admelog sales stopped growing once Lilly further cut prices of its own unbranded Insulin Lispro Injection product by an additional 40%), the PBM demands for rebates had kind of curtailed Admelog sales growth after 2022.

In 2022, Sanofi eventually joined Lilly and Novo Nordisk's move which had started back in 2019 when they each introduced "unbranded" versions of their bestselling insulin products as a way to counteract the PBM price inflation when Sanofi introduced Winthrop by Sanofi Insulin Glargine Injection (rDNA origin, 100 units/mL) in 2022. I blogged about that when it happened, see my post at https://blog.sstrumello.com/2022/06/sanofi-joins-ranks-of-35vial-insulin.html for more). That product was more than 70% cheaper than brand-name Lantus. However, note that Lilly and Biocon's copies of Lantus are merely the first few copies of Lantus to hit the market. A whole bunch more copies of Lantus from Sandoz, Amphastar Pharmaceuticals, Lannett Company, Civica's CivicaScript unit, and a few years from now, another from Meitheal Pharmaceuticals are all expected to potentially hit the market, which would render insulin glargine as the most-copied insulin in the U.S. when all of the dust settles. That would mean that insulin glargine products from different manufacturers could soon become commoditized where lowest price wins. I would not be surprised if we could someday see private-label versions of insulins sold under the CVS, Walgreens or even Kroger Pharmacy retailer names when so much competition exists.

Of course, in March 2024, Lilly, Novo Nordisk and Sanofi all collectively announced they would be abandoning the rebate-contracting sales model promoted by the major PBMs for the insulin therapeutic class of drugs, and each has slashed the list prices on their top selling insulins by more than 70%. In Germany, where Sanofi's insulin began shortly after the discovery of insulin made by a company then known as Hoechst (years later, Sanofi would acquire the Canadian innovator of insulin known as Connaught Laboratories), it also sold a line of biosynthetic "human" insulins under the brand-name "Insuman", although it never sold Regular or Isophane/NPH in the U.S. because Lantus had become its sole revenue-generator. The Insuman brand of insulin products was discontinued in the UK market in 2023, although it may still exist in Germany and Austria.

Naturally, Sanofi's basal insulins including Lantus, and its unbranded version of Lantus sold by its Winthrop business unit called Insulin Glargine Injection 100 units/mL, as well as a very high concentration version of glargine in 300 units/mL potency branded as Toujeo remain for sale. But on the prandial insulin front, Sanofi still sells its proprietary Apidra (insulin glulisine, 100 units/mL) which has been FDA approved since 2004, but it also sells its copy of Lilly's Humalog (insulin lispro, 100 units/mL) which was approved as a follow-on biologic on December 11, 2017, and most recently, on February 14, 2025 Sanofi also received FDA approval to sell a copy of Novolog (insulin aspart, 100 units/mL) which was approved as a biosimilar (catch my coverage at https://blog.sstrumello.com/2025/02/fda-approves-merilog-insulin-aspart.html for more). But with the addition of Sanofi's prandial insulin Apidra (insulin glulisine, 100 units/mL), that means Sanofi is the only insulin manufacturer which sells all prandial insulin molecules on the market (FYI, newer prandial insulins including Fiasp and Lyumjev have slightly expedited AMDE profiles thanks to additions made to the insulins' buffer solutions, but are not new insulin molecules).

This also means that for the moment, Sanofi is the only insulin manufacturer which sells insulin glargine, glulisine, lispro and aspart. In other words, Sanofi is the only manufacturer who currently makes and sells every prandial insulin molecule except for Regular in the U.S. Note that next-generation prandial insulins including Novo Nordisk's Fiasp (the name is an acronym for "Faster Insulin Aspart") is essentially Novolog with the addition of Niacinamide [vitamin B3] added to the buffer solution, while Lilly's next-generation prandial insulin branded as Lyumjev is insulin lispro (Humalog) with the addition of citrate and treprostinil in the buffer solution. In other words, neither Fiasp nor Lyumjev are fundamentally new insulin molecules, just slightly expedited ADME profiles thanks to some additives included in the liquid. That's also why those products are really not too much faster than the originals.

However, the fact that Sanofi even applied for FDA approval to sell a copy of Novolog (branded as Merilog) suggests that Sanofi views business opportunity in biosimilar insulins. In Europe, biosimilars are a major part of Sanofi's insulin sales, and evidently, the company sees the same potential in the U.S. In some ways, it was a learning experience to understand how applying for a biosimilar is approved with the FDA compared to the old approval method.

Lilly has done the exact same thing since biosimilars became a thing when its second copy of Sanofi's Lantus branded as Rezvoglar hit the market on April 1, 2023. Novo Nordisk is the only major insulin supplier which has yet to introduce any biosimilars, hence that company has no experience with the comparatively new approval process at the U.S. Food and Drug Administration (FDA).

It now looks as if Sanofi is also about to start selling its insulin products via Mark Cuban Cost Plus Drug Company https://www.costplusdrugs.com/medications/ (MCCPDC) with its low prices and fixed, 15% markup. While the website says that Sanofi insulin "isn't currently available on the CostPlus platform", if you search for the names of say Apidra or Lantus, all of the Sanofi insulins now appear. Some may recall that MCCPDC had initiated a trial introduction of Lilly Insulin Lispro (the unbranded version of Humalog), but the trial ended about a year later. I believe that was about the time when it introduced an innovation known as the "Team Cuban Card" https://www.teamcubancard.com/.

MCCPDC has been expanding its retail footprint nationwide via the Team Cuban Card which it says is now accepted at most national grocery chain pharmacies as well as various other independent pharmacies as well. Where I live, that would be my local Stop & Shop Pharmacy. Maybe it's a Kroger Pharmacy near you, or a Safeway Pharmacy, or a Vons Pharmacy or a Ralphs Pharmacy or a Meijer Pharmacy where you happen to live. Team Cuban Card enables patients to get a discount card in their own name (there is no charge, but they require each patient to have their own card), and you can enjoy the lower prices which MCCPDC is known for. Team Cuban Card also enables people to buy their insulin at a local pharmacy without having to rely on shipping via UPS or FedEx, which is often problematic during the summer months when insulin (even with ice-packs in the packaging) can sometimes destroy insulin thanks to packages sitting in warehouses at temperatures of more than 100 degrees Fahrenheit for a number of hours, which can literally cook your insulin before it arrives. Thanks to retail pharmacies deliveries having temperature controls for certain medicines including insulin, the same problem seldom happens on retail pharmacy pick-ups.

FDA Approves Merilog (insulin-aspart-szjj) as First Prandial Insulin Biosimilar Product for Treatment of Diabetes

My followers might recall my groundbreaking January 8, 2007 article (see that at https://blog.sstrumello.com/2007/01/business-of-diabetes-real-story-behind.html for more) which followed a long discovery process which began back in 2006 based upon a very simple question: the patents on biosynthetic insulin had expired, so why did Americans have no generic products to help reduce prices?

As it turned out, the answer was unnecessarily complicated. It was complicated by design from entities who benefitted from not having generic or biosimilar competition. And, I don't mean pharma as such, but from vertically-integrated (with commercial healthcare insurance companies) Pharmacy Benefit Managers (PBMs) who were behind the scenes, demanding ever-larger legally-exempt rebate kickbacks for preferred formulary positioning. Those demands for bigger rebates led to list-price inflation.

There were a variety of other factors involved, including the fact that insulin was the very first-ever biologic medicine which was approved back in 1982, but it had been regulated as a small-molecule "drug" whose manufacture just so happened to be regulated as the manufacture of a biologic medicine. Also, Federal lawmakers had not explicitly legalized copies of biologic medicines until Democrats in Congress (not a single Republican lawmaker voted for it) passed the Biologics Price Competition and Innovation Act (BPCIA) in 2019, which was a key provision of the Patient Protection and Affordable Care Act (aka Obamacare) which explicitly legalized biosimilar medicines in the first place, including outlining of procedures which must be followed by pharma to attain FDA approval.

But beyond that was the uncomfortable reality that FDA policy had still failed to recognize insulins which had originally been approved by FDA as small molecule "drugs" (which were manufactured as biologic medicines) were even eligible for biosimilar competition, and the FDA took nearly a decade after the Patient Protection and Affordable Care Act became law before it finally implemented policies to do that. It was under former Trump FDA Chief Scott Gottlieb that FDA finally did that in spite of being repeatedly prompted by lawmakers to do so, and only because the FDA itself had failed to implement those policies for nearly a decade. On the latter, it is believed that Lilly, Novo Nordisk and Sanofi had quietly encouraged their former colleagues then working at FDA to keep delaying those policies in an effort to prevent any competition from coming to market for as long as possible.

That said, what I originally referred to as "generic" (FDA referred to those "follow-on" biologics, which subsequently became known as biosimilars approved under a slightly different regulatory pathway at FDA) insulins eventually happened anyway. 

Originally, the "follow-on" biologic insulins came to market first because FDA's own dysfunctional policy enabling biosimilars had not yet been formally implemented. Once FDA finally got its $#!+ together and implemented policies required under U.S. law, that finally enabled true biosimilars to come to market.

Which brings me to last week's FDA announcement (see https://www.prnewswire.com/news-releases/fda-approves-first-rapid-acting-insulin-biosimilar-product-for-treatment-of-diabetes-302377321.html for the news release) that FDA had officially approved the first biosimilar copy of Novolog (insulin aspart injection, 100 units/mL) to be made by Sanofi Aventis LLC whose trade name will be known as Merilog (insulin aspart-szjj). Observe the color scheme used for Merilog: orange, which is the same color Novo Nordisk uses in boxes containing Novolog.

The FDA package insert (see https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761325Orig1s000lbl.pdf for the insert itself) and the outer box for Merilog includes proposed images (Sanofi will use the color orange also used by Novo Nordisk for Novolog for the newly-approved Merilog product, rather than the maroon color which it uses for the follow-on biologic branded as Admelog). The image is of the proposed box containing a 10 mL vial. Note how the package indicates that Merilog is a "Product of Germany" meaning Sanofi is importing the product (for the time-being, anyway).

Sanofi already sells a copy of Lilly's Humalog (insulin lispro injection, 100 units/mL) sold under the brand/trade name "Admelog" which was approved by FDA on December 11, 2017 (see the FDA news release on that at https://www.prnewswire.com/news-releases/fda-approves-sanofis-admelog-insulin-lispro-injection-300569676.html for more). In 2019, I blogged about my trial of Admelog (which I erroneously referred to as a "biosimilar" instead of a "follow-on biologic", and I found that worked pretty much as Humalog did, without the hassle of adjusting ratios necessitated by switches to other competing prandial insulins like Novolog, Fiasp or Apidra all required.

However, unlike Admelog, Merilog has been approved as a "biosimilar", rather than as a "follow-on biologic" medicine. The differences are that: a) the approval pathway at FDA was different for Admelog vs. Merilog, and b) as a "biosimilar", Sanofi could theoretically later seek a designation as "interchangeable" from FDA which would enable pharmacists to switch to Merilog without the prescribing doctor's permission unless the doctor designates the prescription "Prescribe as Written" or "No Substitution Permitted" on the prescription. The FDA approval of Merilog also brings a long-standing delay at FDA to a close. The FDA had only two previous insulins which were approved as "biosimilar" drugs, specifically Semglee (insulin glargine-yfgn) which was first approved by the FDA in June 2020 (and subsequently received approval as an "interchangeable biosimilar" to innovator Sanofi Lantus on July 28, 2021), and a second copy of Lantus made by Eli Lilly & Company, Inc. which is sold under the trade name Rezvoglar (insulin glargine-aglr) which received FDA approval in December 2021. This means that for three years, FDA had not rendered any decisions on biosimilar insulins, although truthfully, Covid-19 shutdowns delayed many FDA decisions.

To my knowledge, Sanofi only sells vials and Solostar prefilled pens of insulin, but it does not currently sell 3 mL cartridges of insulins as both Novo Nordisk and Lilly do (the latter sells pen cartridges only for certain varieties of prandial insulin analogues only) which would work with refillable, smart insulin pens such as Medtronic's InPen which automatically logs each dosage given with the pen enabling patients to easily track insulin on-board.

Of course, if PBMs are involved, they will just non-medically switch patients anyway by disregarding the FDA designation and calling the products "therapeutically equivalent" in order for the PBM to try and collect legally-exempted rebate kickbacks (although in 2023-2024, Lilly, Novo Nordisk and Sanofi all effectively opted-out of the rebate-contracting sales model for the insulin therapeutic class of drugs).

There is also a photo of the Solostar prefilled insulin pen on the package insert given to the FDA. Of note is that under Section 16, which is entitled "HOW SUPPLIED/STORAGE AND HANDLING", and more specifically under Section 16.1, where it describes "How Supplied," it says that MERILOG (insulin aspart-szjj) injection 100 units/mL (U-100) is available as a clear and colorless solution in one 10 mL multiple-dose vial per carton (which is assigned the NDC # 0024-5927-00),  or in five 3 mL single-patient-use SoloStar prefilled pens per carton (which is assigned the NDC # 0024-5928-05). It also adds "The MERILOG SoloStar prefilled pen dials in 1-unit increments" (rather than 1/2 unit increments).

With all that said, while Novolog will experience its first biosimilar copy, there are quite a few others, most of which are pending FDA at this very moment. As a reminder, those could be from (which I documented them in a previous post found at https://blog.sstrumello.com/2023/09/another-three-biosimilar-insulins.html):

• Biocon Biologics, Inc. (in Feb. 2023, FDA denied Biocon's aspart biosimilar application with a Complete Response Letter (CRL), indicating that Biocon first needed to address some deficiencies which FDA had cited before FDA would approve it, and Biocon told investors that it intended to fix those things)
• Sandoz/Gan & Lee 
• Civica, Inc.'s CivicaScript PBC operating unit/GeneSys Biologics
• Amphastar Pharmaceuticals/ANP
• Lannett Company, Inc./YiChang HEC ChangJiang Pharmaceutical Co., Ltd. [HEC]

About five years behind those companies' aspart biosimilars, a sixth copy from Meitheal Pharmaceuticals/Tonghua Dongbao Pharmaceutical Co. Ltd. is also in development, but as noted, that Chicago-based company is a few years behind the others in terms of development.

These just so happen to be the publicly-held (or, in the case of Lannett Company, a formerly publicly-held) companies I know about. It's possible there could be others based outside the U.S. which also intend to make Novolog biosimilar copies as well.

As for Novo Nordisk, Inc. (the U.S.-based subsidiary of Denmark-based Novo Nordisk A/S whose headquarters are in Plainsboro, NJ [which borders Princeton]), my expectation is that the company is likely to simply discontinue (or "retire" in company parlance) the original insulin aspart and focus exclusively on its slightly-improved Fiasp (the name derived from "Faster Insulin ASPart") which works marginally faster thanks to the addition of vitamin B3 into the buffer solution, which still retains patent exclusivity for the time-being. Novo Nordisk has retired more than a dozen still-efficacious insulin varieties over the past 25 years because they no longer enjoyed Intellectual Property (IP) rights. Levemir happens to be the latest, but I predict Novolog will be "retired" before too long because copies of the product are now being sold.

The difference this time around is unlike in the past when patients were forced to "upgrade" to Novo Nordisk's newest, patent-protected insulin varieties, if patients wish to keep using original insulin aspart, they will likely be able to use Sanofi's Merilog or any of the others currently pending FDA approval decisions.