New Insulin Approval Pathway Could Increase Competition


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The U.S. Food and Drug Administration (FDA) has announced a new regulatory pathway for biologic drugs, including insulin, aiming to simplify the approval process for biosimilar insulins. The new pathway will also simplify the process for labeling biosimilar insulins as interchangeable with their existing product counterparts.  In their statement, the FDA shared that the new regulatory pathway “is expected to increase patient access, adding more choices and potentially reducing costs of these vital therapies.”

Biologics are pharmaceuticals that are made from living organisms. The first biologic drug for any condition was human insulin, first marketed in 1982, but other biologics include things like vaccines. Until now, biologics were regulated through the same pathways as any other drugs under the Federal Food, Drug and Cosmetic (FD&C) Act.

Under the new framework, all biologics will now be approved through their own pathway, regulated under the Public Health Service Act. The act has been instated after a 10-year transition process started by the US Congress’ Biologics Price Competition and Innovation Act of 2009.

The Public Health Service Act places biosimilar insulins into the same regulatory pathway as their biologic counterparts. Biosimilars are essentially the generic versions of biologics, but the term generic only applies to fully synthetic drugs. Biosimilar is the term used for products that are made from living organisms.

Biosimilars were previously being routed through an abbreviated pathway in the Federal Food, Drug and Cosmetic (FD&C) Act. Because they were being routed through their own pathway, they were not able to be listed as interchangeable with their biologic counterparts.

By placing biologics and biosimilars in the same pathway, separate from other types of drugs, biosimilar insulins will be listed as interchangeable with their existing product counterparts. This may create greater competition within the insulin market, and ensures that those living with insulin-dependent diabetes have a variety of reliable treatment options to choose what is best for them. 

Once biosimilar insulin comes to market, the FDA expects to see more market competition, potentially lowering prices of insulin. While it is unclear how much the availability of interchangeable biosimilars will affect the market, one FDA analysis shows that just one generic drug on the market lowers drug prices by 31 to 39 percent. 

Leading up to biosimilar market offerings, the FDA has also been working with the Federal Trade Commission (FTC) to ensure all biologic and biosimilar insulin manufacturers go to market with accurate statements in all promotional communications. Both organizations are aiming to deter any anti-competitive business practices within the biologic and biosimilar insulin market. 

Leaders at the FDA look forward to the new regulatory pathway “ultimately empowering patients by increasing choices and potentially lowering prices of safe, effective, high-quality medications.”

If you or a loved one are struggling to afford insulin, learn more about the options that exist here.

WRITTEN BY Lala Jackson, POSTED 03/24/20, UPDATED 08/04/23

Lala is a communications strategist who has lived with type 1 diabetes since 1997. She worked across med-tech, business incubation, library tech and wellness before landing in the type 1 diabetes (T1D) non-profit space in 2016. A bit of a nomad, she grew up primarily bouncing between Hawaii and Washington state and graduated from the University of Miami. You can usually find her reading, preferably on a beach.