Why Reform Hasn't Reached the Pharmacy Counter Yet

Since 2025, the FDA has approved THREE (3) biosimilar copies of Novolog (depicted in the image above, [from L to R] including the newest called Garzulys which was approved in 2026, as well as Kirsty which was also approved in 2026, and Merilog which was approved in 2025), and yet few U.S. patients realize they even exist. People whose pharmacy benefits are administered by Express Scripts (and by extension, Prime Therapeutics) have been forced to adopt Biocon Biologics' insulin biosimilars, but does this necessarily mean biosimilars hold the key to affordability?

So far, biosimilars have barely made an impact.

Dr. Kasia Lipska, an endocrinologist and researcher at the Yale Diabetes Center in New Haven, Connecticut co-authored a study showing that people treated there were still rationing insulin at the same rate in 2024 as in 2017. About one in four people reported rationing due to cost, but when including insurance delays and supply limits, more than one in three (38%) struggled to keep insulin on hand (see https://medicine.yale.edu/news-article/insulin-rationing-persists-despite-policy-changes-study-shows/ for news about the study). 

Dr. Lipska said "There's just still a lot of holes in one who is covered by various protections and then how they're covered and how they access this" adding "It's not as simple as just showing up at the pharmacy and asking for your insulin, and the sticker price is there, and that's what you pay. It's extremely complicated."

Her second statement may be an understatement which few people understand.

Thanks to more than a decade of kickback-driven (which PBMs call "rebates") formulary-exclusions, which the Federal Trade Commission (FTC) sued over in 2024, and securing settlement agreements in 2026 from several of the biggies, we are finally starting to see meaningful changes on that front, but another issue is that every existing employer contract + any contract renewal are not yet impacted by those FTC-PBM settlements. They apply only to new PBM contracts. But when employers' new PBM contracts are signed, then covered patients could finally realize a benefit from those legal consent agreements. However, this is also impacted by PBM retail pharmacy contracts, which essentially dictate that cash-paying customers end-up paying the highest prices of any payer, which means that coupons are the only work-around to that reality.

There's another wrinkle: thanks to the American Rescue Plan of 2021, that law removed a cap on rebates which are reimbursable to Medicaid, effectively forcing innovators of older, very heavily-rebated drug classes such as insulin to either slash their list prices by more than 70%, or else pay Medicaid for those drugs to be included on the Medicaid formulary. The result was branded Novolog (and its competitors') list prices have fallen significantly as of 2025. 

You can see evidence of the insulin list price reductions in the data. 46brooklyn Research offers a tool called "Brand Drug List Price Change Box Score" which is accessible at no charge to anyone at https://www.46brooklyn.com/branddrug-boxscore/, but using it takes some practice. If you don't want to look-up the numbers for yourself, it's not necessary. GoodRx published a study in January 2025 showing the same insulin list price reductions (see https://www.goodrx.com/healthcare-access/research/how-much-does-insulin-cost-compare-brands) for the GoodRx study/article which may be easier to digest). That was also the reason Sanofi felt comfortable eliminating its unbranded version of Lantus in March 2026. Its move followed rival Novo Nordisk which discontinued its unbranded insulin products around the same time. 

Only Lilly now continues selling its unbranded version of Humalog, and the reason is because Lilly revealed to investors two years after introducing the unbranded insulin product, that the unbranded version of Humalog accounted for nearly a third of domestic Humalog sales at the time. Now, the unbranded insulin lispro product outsells branded Humalog in the United States. Patients think they are using a biosimilar, when it's really just branded Humalog being sold under the generic drug name. 

Remember: many patients have yet to experience the list price reductions as the Yale research showed. Cash prices are artificially-inflated (including patients using insurance with unsatisfied deductibles) due to retail pharmacy contracts with PBMs, plus deductible credits are currently based on the deeply-discounted "net" price which the insurance company pays, effectively making covered patients pay...TWICE. The PBMs which have settled with FTC have actually agreed to substantive changes, but the settlements specify their implementation dates "as soon as commercially feasible, but no later than the implementation of Month DD, YYYY [specified in the settlement agreements]".

In essence, the U.S. prescription drug market is an incredible mess which is caused by every entity involved in distribution trying to skim some margin from it. 

And for patients, navigating this dysfunctional mess is anything but simple.

That's why the Yale University study found that people treated there were rationing insulin at the same rate in 2024 as they were in 2017.

Behind the scenes, no one can say that meaningful changes are not happening. 

But fixing this big mess is also no small undertaking and it there are a lot of different moving parts involved in resolving this. How important biosimilars end up being in the U.S. market remains an open question. 

One player, specifically the CivicaScript operating unit of Civica Rx, is attempting to bypass traditional drug wholesaler and PBM markup schemes using a Unilateral Pricing Policy (UPP) https://civicascript.com/upp/, which establishes a strict maximum price that retail pharmacies can charge to consumers. 

Following its January 2026 introduction of a Biocon Biologics-manufactured biosimilar insulin glargine product, Civica has made a box of five prefilled pens available for no more than $55, demonstrating that transparent, capped pricing at the counter for patients is actually possible when a manufacturer intentionally limits intermediary margin. But knowing where it can be purchased remains an issue. Big chains like CVS and Walgreens benefit from inflated list prices. Also, Civica has yet to introduce its own version of Biocon Biologics' Kirsty, but we know one is coming because it was announced in 2025. 

When will patients start to see prices fall? Some covered by employer-sponsored commercial health insurance plans with deductibles are now covering insulin PRE-DEDUCTIBLE, and I am benefitting from that, except that I've been forced to non-medically switch to a different insulin brand "preferred" by my insurance plan which happens to be Novo Nordisk under my Aetna plan. At least it's covered. And with the FTC settlement agreements, a provision about TrumpRx purchases means that all manufacturers' direct-to-patient sales efforts, the insurance plan will have to also cover insulins bought even if they are not on-formulary. That means I will at some point be able to use Lilly's Humalog if I buy from LillyDirect, rather than Novo Nordisk's Fiasp. It means an end to routine non-medical switching of insulins unless I agree. That, in my view, that's still a big deal. 

No one is saying this will happen quickly, but meaningful changes are underway.