The most heavily copied insulin analogue in the U.S. right now is Sanofi's Lantus (insulin glargine injection 100 units/mL rDNA origin). Quite a few different copies of Lantus are already now on the market, and a number more are approaching FDA approval decisions. The precise count varies, depending on whether one considers different NDC numbers for the same molecule to represent distinct products as legitimately different insulin products or not. But the underlying business assumption was seemingly straightforward: because Lantus was the single bestselling insulin in the U.S., it seemingly represented the largest commercial opportunity for biosimilar insulin manufacturers.
However, there is more to the story than gross sales alone.
When a market is divided among nine or ten competing products, pricing flexibility declines and profit margins compress. That applies to biosimilars, too. By contrast, Levemir (insulin detemir) generated nearly $650 million in revenue for Novo Nordisk in 2022, captured approximately 10% of the U.S. insulin market, and currently has zero follow-on biologic or biosimilar competitors. As a result, already-rendered business assumptions, and changing U.S. insulin market dynamics in which PBM rebate-contracting for insulin molecules are creating a very lucrative but overlooked business opportunity in insulin detemir biosimilars.
Back in 2023, I was introduced to a group of patient activists who were upset by Novo Nordisk's unilateral decision to discontinue Levemir in order to focus manufacturing capacity on more lucrative weight-loss drugs. They became known as the Alliance to Protect Insulin Choice https://alliancetoprotectinsulinchoice.org/. Novo's decision to discontinue selling Levemir came after the last U.S. patents on Levemir had expired, leaving Novo Nordisk with no Intellectual Property (IP) rights to defend if biosimilar manufacturers stepped in. I had experienced the adverse effect (of the abusive business practice) of insulins being discontinued repeatedly over my half-century with T1D, and I did not want to see a whole new generation of younger people be forced to endure that, and I also learned some things I did not know when I went through it the first time, so I pushed for passage of laws to try and prevent it from happening routinely again.
In September 2024 testimony before lawmakers, Novo Nordisk's CEO claimed that Levemir sales were, in effect, plummeting, yet he provided no detailed data to substantiate that assertion. Readers may review the hearing transcript at https://www.rev.com/blog/transcripts/senate-hearing-on-weight-loss-drugs/.
Publicly available data suggested otherwise on plummeting Levemir sales.
According to data derived from the federal government's Medical Expenditure Panel Survey (MEPS), which is conducted by the Agency for Healthcare Research and Quality (AHRQ), that showed prescriptions for Levemir remained remarkably consistent over time. The MEPS database is available at https://meps.ahrq.gov/mepsweb/. Pharmacists and Pharmacy Technicians often rely on better-organized tools such as ClinCalc's DrugStats database (available at https://clincalc.com/DrugStats/) to access and analyze the underlying MEPS data.
Levemir ranked as the 117th bestselling drug in the U.S., accounting for 5,214,067 prescription fills dispensed to 1,027,442 unique patients. According to diaTribe News, Levemir generated nearly $650 million in revenue for Novo Nordisk during 2022. The diaTribe article is available at https://diatribe.org/diabetes-medications/levemir-long-acting-insulin-be-discontinued-novo-nordisk.
Levemir is also unique as the only basal insulin specifically-labeled for use during pregnancy, and also the only basal insulin that can be safely diluted for use in insulin-sensitive patients such as in infants. Newer basal insulins were designed largely to sell to insulin-naive Type 2 diabetes patients with a benefit of less frequent dosing, yet newer basal insulins lacks specific labeling for use in pregnancy, nor can they safely be diluted.
When I first learned that Levemir would be discontinued, my immediate reaction was simple:
"Again?! How many fµcking times will patients be forced to endure such egregious business practices?"
Over fifty years living with Type 1 diabetes (T1D), and I have experienced multiple discontinuations of still-efficacious insulins and routine non-medical switches resulting from those. By 2019, sixteen different biosynthetic 'human' insulin products had already been listed as "discontinued" in the FDA's Orange Book (six of which were from the Lente series of insulins alone formerly made by both Novo Nordisk and Eli Lilly). Historically, patients were told these changes were being made for our own benefit, although the replacements seldom improved glycemic control. More often, they simply increased patients' costs and made patients' lives generally more difficult.
This time, however, the situation was different.
When Eli Lilly discontinued Iletin II Pork Insulin back in 2005, followed by the discontinuation of Humulin U [Ultralente] and Humulin L [Lente], no legal pathway existed at the time for competitors to produce copies of those insulin molecules. Today, that is no longer the case.
What was impossible nearly 20 years ago from a legal and regulatory perspective is now a realistic and established regulatory process which patient activists including me helped to ensure existed.
In 2009, Congress passed the Biologics Price Competition and Innovation Act, creating a regulatory framework for biosimilars. A decade later, in 2019, the FDA formally recognized insulin products as biologic medicines, effectively making them eligible for biosimilar approval pathways for the first time ever. The archived copy of the FDA's announcement is available at https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-scott-gottlieb-md-agencys-continued-efforts-bring-competition-insulin/.
That reality gave patient advocates something we originally lacked during all prior efficacious insulin discontinuations: a viable legal pathway to help restore access through market competition. At the same time, my own role was transformed to enable me to assist younger patient activists understand not only the regulatory pathway which I had fought so hard to see implemented, but also to lay out the business case for a biosimilar of Levemir. I knew which companies were already developing insulin biosimilars, how the approval pathways worked, and what economic arguments might persuade manufacturers to [re]consider insulin detemir.
I first began writing about the absence of generic (which became known as) biosimilar insulin back in 2006 and 2007. My original reporting can still be found at https://blog.sstrumello.com/2007/01/business-of-diabetes-real-story-behind.html. The core argument for biosimilar insulin was straightforward.
"Glargine may be the bestselling insulin, but when you are forced to divide that market eight or ten ways, it means far less pricing elasticity, making the economics of a slightly smaller detemir biosimilar, which does not have to be divided at all, look far more attractive. Glargine is poised to become a low-priced commodity, where it will be tougher to make a profit, while detemir biosimilars will not be."
That argument rests upon a rather dramatic evolution of the U.S. insulin market (none of which was accidental, incidentally).
The following chronology illustrates how rapidly the U.S. insulin glargine market has become crowded, with multiple follow-on biologic, biosimilar, authorized generic ("unbranded"), and white-label versions now competing for market share.
- On December 16, 2015, the U.S. Food and Drug Administration granted approval to Lilly's Basaglar (insulin glargine injection 100 units/mL). Although often discussed alongside biosimilars, in fact, Basaglar was approved as a "follow-on biologic" under a regulatory pathway which has since been discontinued. The FDA approval letter for Basaglar remains available at https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205692Orig1s000ltr.pdf.
- On July 28, 2021, the FDA approved Semglee (insulin glargine-yfgn injection, 100 units/mL) as the first interchangeable biosimilar to Lantus https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761201Orig1s000ltr.pdf. Observe that the original drug company "sponsor" of Semglee was Mylan (which subsequently merged with another company to become Viatris) before selling its half of a biosimilars joint venture to its partner Biocon Biologics in 2022.
- On December 17, 2021, the FDA approved Rezvoglar (insulin glargine-aglr injection, 100 units/mL) as an "interchangeable" biosimilar to Lantus. The approval letter is available at https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/761215Orig1s000Approv.pdf. This also marked Eli Lilly & Company's first interaction with a completely new FDA regulatory pathway for insulin molecules (including biosimilars) being formally governed as biologics rather than drugs previously governed under the Federal Food Drug & Cosmetics Act (which was insulin's traditional regulatory scheme).
- On June 30, 2022, Sanofi introduced an "unbranded" version of Lantus marketed as Insulin Glargine Injection, 100 units/mL through its Winthrop by Sanofi unit. My original coverage on that introduction is available at https://blog.sstrumello.com/2022/06/sanofi-joins-ranks-of-35vial-insulin.html. However, two years later, Sanofi slashed the list price of branded Lantus by 78% effective January 1, 2024. The price reductions were driven in part by the elimination of a cap on rebates which are payable to Medicaid, which took effect January 1, 2024 (a detailed explanation is available from KFF at https://www.kff.org/medicaid/what-are-the-implications-of-the-recent-elimination-of-the-medicaid-prescription-drug-rebate-cap/). Sanofi's announcement of the insulin list price reduction can be viewed at https://www.globenewswire.com/news-release/2023/03/16/2629188/0/en/Press-Release-Sanofi-cuts-U-S-list-price-of-Lantus-its-most-prescribed-insulin-by-78-and-caps-out-of-pocket-Lantus-costs-at-35-for-all-patients-with-commercial-insurance.html. We know the branded Lantus price cuts actually happened, because we can see the historical list price changes through a free, online tool maintained by 46brooklyn Research at https://www.46brooklyn.com/branddrug-boxscore/. However, we also know that Winthrop by Sanofi stopped selling unbranded Lantus on March 31, 2026 (see https://healthprovidersdata.com/hipaa/codes/NDC_0955-1729.aspx for details) following the 78% list price reduction of the branded innovator product Lantus. Presumably, unbranded insulins are no longer truly necessary anymore; rival Novo Nordisk did the same thing when it stopped selling unbranded versions of Novolog and Tresiba. While Lilly still sells its unbranded Humalog, the reason is mainly because that unbranded product actually sells more than brand-name Humalog does in the U.S. right now.
- Biocon Biologics also now commercializes insulin glargine through different "white-label" arrangements, including CivicaScript's insulin glargine injection 100 units/mL and CalRx insulin glargine injection 100 units/mL.
- Most recently, on May 4, 2026, Lannett Company, Lanexa Biologics, and Sunshine Lake Pharma collectively announced they had received FDA approval of LANGLARA (insulin glargine-aldy injection, 100 units/mL) as yet another "interchangeable" biosimilar to Lantus. https://www.businesswire.com/news/home/20260504761789/en/Lannett-Company-Lanexa-Biologics-and-Sunshine-Lake-Pharma-announce-FDA-Approval-of-LANGLARA-an-Interchangeable-Biosimilar-of-Lantus-insulin-glargine/.
- We also know that other biosimilar insulin glargine products from Sandoz/Gan & Lee and Amphastar Pharmaceuticals/ANP, and Meitheal Pharmaceuticals/THDB are all awaiting FDA approval decisions on their glargine biosimilar products in the foreseeable future.
In practical terms, with each new copy of Lantus which hits the market, insulin glargine increasingly becomes more of a commodity whereby lower prices tend to win sales. Unfortunately, that tends to support big PBMs more than patients, although a concurrent branded/white-label product strategy enables biosimilar makers to sell biosimilars both ways, which is a new twist.
Novo Nordisk spent decades introducing one new basal insulin analogue after another, yet never quite succeeding in displacing Lantus as the bestselling basal insulin in the U.S.
In my own blog posts, I have occasionally pejoratively referred to these successive basal insulin analogues as Novo Nordisk's newest [or latest] "Lantus killer". Underlying this strategy was what appeared to be a longstanding company presumption that Novo Nordisk was somehow "entitled" to dominate the basal-only Type 2 diabetes market, even though it never quite succeeded.
Its weekly basal insulin branded Awiqli was eventually approved in the U.S., but only for the "indication" of Type 2 diabetes (not for T1D in spite of the fact that 100% of T1D patients are insulin users), as the FDA expressed major concern about the risk of how medical personnel might be asked to address accidental overdoses in the T1D patients (such as accidentally switching their prandial and basal insulin dosages). And several rivals also have weekly basal insulins now in development, which means the newest "Lantus killer" seems unlikely to succeed in actually displacing cheaper glargine.
Novo Nordisk's explanation for discontinuing Levemir therefore also deserves closer scrutiny.
Because Pharmacy Benefit Manager (PBM) formulary managers may "prefer" entire manufacturer portfolios rather than individual insulin products, Levemir and Tresiba were frequently allowed to co-exist on the exact same drug formularies. Levemir patients had little incentive to switch voluntarily from one Novo Nordisk basal insulin to another, hence they did not.
Novo Nordisk disclosed to investors in 2022 that Tresiba sales had finally surpassed Levemir sales (albeit marginally) for the first time since being introduced in 2015 (seven years after approval). That proved Levemir remained commercially viable, hence the only real way to accelerate adoption of Tresiba was for Novo Nordisk to simply eliminate internal competition altogether. Expired IP rights was a convenient excuse, just not a terribly persuasive one.
There was also another factor.
Novo Nordisk is/was struggling to meet demand for Wegovy, its high-priced obesity treatment. Fill & finish manufacturing capacity at the company is finite even with its acquisition of Catalent, and weight-loss drugs command higher margins than more-commoditized insulins. From a purely financial perspective, shifting production away from Levemir and toward obesity drugs was an entirely rational "business" decision. That may explain why a product that still generated nearly $650 million in annual revenue and retained clinically unique attributes was simply withdrawn from the market. After all, its newer basal insulin products cannot really point to improved glycemic control over Levemir, which was the way Novo Nordisk had previously positioned its withdrawal of other still-efficacious insulin products.
For patients, however, the consequences of routine insulin "retirements" are still significant.
Levemir is not merely an older basal insulin analogue. It remains uniquely relevant and valuable to pregnant women, infants who require dilution of their basal insulin, as well as the nearly 1 million long-term users who achieved stable glucose control with it. The disappearance of such a product highlights how corporate portfolio decisions can abruptly eliminate effective treatments that remain medically important and commercially viable.
Yet the central lesson is that the largest molecule on the market is not always the most lucrative market. Lantus may once have appeared to offer the most attractive opportunity for biosimilar manufacturers, yet a crowded market with declining prices can quickly become less profitable than a slightly smaller market like detemir with no competition. I created this animated graphic to demonstrate the underlying market dynamic.
The Mirage of Market Share vs. Reality
Market share looks large—until you see how many players are fighting for each molecule
Seen in that light, insulin detemir may represent a lucrative business opportunity not to replace existing biosimilar strategies, so much as to complement them. Those investments in Lantus copies have already been made and the manufacturers must now make them work profitably. But for manufacturers already competing in increasingly commoditized molecules such as insulin glargine, adding a detemir biosimilar could provide them with a higher-margin product with no direct biosimilar competition and clinically meaningful differentiation. That spells a more attractive biosimilar insulin strategy than chasing the bestselling molecule alone. And remember: Sanofi has already slashed branded Lantus prices by 78%, hence the price differential on biosimilar products will be more closely examined.
The detemir opportunity may be even broader because the U.S. insulin market's business dynamics have been fundamentally reset in recent years thru government legislation, litigation, and competitive responses that have collectively weakened the PBM rebate-contracting sales model which once dominated the insulin therapeutic class. Companies willing to diversify access points through direct-to-patient sales models, cost-plus pricing arrangements, and potentially securing FDA Rx-to-OTC relabeling (more accurately described as "BTC" for behind-the-counter) for detemir, enabling new ways to reach insulin users while also limiting dependence on profiteering traditional gatekeepers like PBMs.
What appears at first glance to be a smaller market may, in fact, offer biosimilar manufacturers a very practical way to complement increasingly commoditized insulin biosimilar products with a clinically differentiated, higher-margin opportunity, helping them to improve their margins. In a U.S. insulin market whose economics have been fundamentally reshaped, insulin detemir biosimilars may represent one of the most compelling strategic opportunities now available.
The Alliance to Protect Insulin Choice https://alliancetoprotectinsulinchoice.org/ has worked tirelessly to bring a copy of insulin detemir to market. While they are still working on this including working with regulators, and pitching the business case to potential biosimilar manufacturers, the organization can report quantifiable progress has been actually made, opening up the possibility that a biosimilar of Levemir would render it as the first insulin being brought back from the dead, and the business prospects look good if they follow the business guidance from Alliance to Protect Insulin Choice.
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