Not So Different: Rep Grothman on His Bill to Make Biosimilar Insulins Interchangeable

A major barrier to biosimilar uptake in the United States involves interchangeability, which is a regulatory designation given by the FDA that allows for switches between a reference product and a biosimilar to occur at the pharmacy level. Currently, there are no biosimilars that have received interchangeability status.

Additionally, now that insulin products are regulated under the Biologics Price Competition and Innovation Act (BPCIA) as a result of a regulatory rule change that occurred in March, biosimilar insulin products also may receive interchangeable designations.

We sat down with Representative Glenn Grothman (R-Wisconsin), the author of HR 8190, a bill that would waive interchangeability requirements for biosimilar insulins, to discuss why this bill is needed for Americans and what it could mean for future biosimilar legislation.

To learn more about HR 8190, click here.
To learn more about the regulatory transition of insulin under the BPCIA, click here.
To learn more about interchangeability designations, click here.