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Not So Different: Rep Grothman on His Bill to Make Biosimilar Insulins Interchangeable
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.
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.
Can Global Policies to Boost Biosimilar Adoption Work in the US?
November 17th 2024On this special episode of Not So Different honoring Global Biosimilars Week, Craig Burton, executive director of the Biosimilars Council, explores how global policies—from incentives to health equity strategies—could boost biosimilar adoption in the US.
Biosimilars Development Roundup for October 2024—Podcast Edition
November 3rd 2024On this episode of Not So Different, we discuss the GRx+Biosims conference, which included discussions on data transparency, artificial intelligence (AI), and collaboration to enhance the global supply chain for biosimilars and generic drugs, as well as the evolving requirements for biosimilar devices.
Biosimilars Policy Roundup for September 2024—Podcast Edition
October 6th 2024On this episode of Not So Different, we discuss the FDA's approval of a new biosimilar for treating retinal conditions, which took place in September 2024 alongside other major industry developments, including ongoing legal disputes and broader trends in market dynamics and regulatory challenges.
Biosimilars Gastroenterology Roundup for February 2023—Podcast Edition
March 5th 2023On this episode of Not So Different, we chronicle the latest gastroenterology news from February, including several updates on adalimumab and infliximab biosimilars and industry analyses on the utilization of these drugs and patient confidence in gastroenterologists’ recommendations.
