PBMs: Applauding FDA Approval of the First Biosimilar Insulin Product

JC Scott
2 min readAug 9, 2021

Day in and day out, Americans are faced with challenges around prescription drug affordability and access. That issue is particularly problematic for many people living with diabetes. On average, insulin manufacturers nearly doubled their products’ prices in just five years.

According to the U.S. Food and Drug Administration (FDA), “more than 34 million people in the U.S. today have been diagnosed with diabetes, which is a chronic (long-lasting) health condition that affects how the body stores and uses sugars and other nutrients for energy.”

In an earlier post, I highlighted the work being done by pharmacy benefit managers (PBMs) to help patients living with diabetes overcome financial barriers to needed medications.

And now we can celebrate the FDA’s approval of the first interchangeable biosimilar insulin product, Semglee, which can be used as an alternative to long-acting Lantus. As the FDA notes, this biosimilar is indicated to improve glycemic control in adults and pediatric patients with Type 1 diabetes mellitus and in adults with Type 2 diabetes mellitus.

I agree with Acting FDA Commissioner Woodcock’s characterization of Semglee’s approval as “a momentous day for people who rely on daily insulin.” For the first time, an interchangeable biosimilar offers competition to an analog insulin. We in the PBM industry hope for many additional such FDA approvals.

PBMs are already leveraging the availability of alternatives, both biosimilars and their reference biologics, as part of an overall strategy to remove costs from the health care system. And with more competitors to branded biologic insulins, prices should moderate and costs should fall. This direct competition, in turn, will lower patient costs.

Recent research from PCMA found that “since the launch of the direct competitor biosimilars, the list price increases have stopped, and for five biologics, the freeze in list prices were paired with decreases in net costs. It is clear that biosimilar-to-biologic competition is playing an important role in containing drug costs.”

Moving forward, PBMs will continue to focus on finding cost-effective, care-oriented solutions for patients living with diabetes and others who rely on prescription drugs for their health. Specifically, PCMA has released detailed policy proposals that promote greater competition and use of generic and biosimilar drugs. As part of this effort, PBMs will use every resource available to ensure that patients have the affordable care they need.



JC Scott

JC Scott is the President & CEO of the Pharmaceutical Care Management Association (PCMA), the association representing America’s pharmacy benefit managers