- Bone Health
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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.
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.
Decoding the Patent Puzzle: Navigating the Legal Landscape of Biosimilars
March 17th 2024On this episode of Not So Different, Ha Kung Wong, JD, an intellectual patent attorney and partner at Venable LLP, details the confusing landscape that is the US patent system and how it can be improved to help companies overcome barriers to biosimilar competition.
AAM's Craig Burton: Is the Biden Administration Doing Enough to Help Biosimilars?
November 13th 2022Craig Burton, senior vice president of policy and strategic alliances at the Association for Accessible Medicines and executive director of the Biosimilars Council, gives insight into the many health policies that the Biden administration has implemented in 2022 as well as their possible impact on biosimilar adoption.
How Health Policy Can Impact Adoption for Adalimumab Biosimilars
September 25th 2022In this episode of Not So Different, Julie Reed, executive director of the Biosimilars Forum, discussed current policy initiatives that could help biosimilar adoption and how the Inflation Reduction Act is expected to influence the adalimumab market.
