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Scott Gottlieb, MD: Congress and the BPCIA
Scott Gottlieb, MD, former commissioner of the FDA, discusses whether Congress should make changes to the Biologics Price Competition and Innovation Act (BPCIA) if the opportunity arises.
Transcript
I think Congress struck the right balance. I think that Congress gave enough flexibility to the regulatory authorities, including FDA, to try to continue to evolve the biosimilar pathway.
I think in terms of the data protection that was provided, it was the right balance to create incentives to continue to invest and innovate while still creating an entry point for lower-cost competition.
I think that the challenge now is continued regulatory improvement to try to make the process more efficient and lower cost so you see more entrants and maybe get the cost down developing a biosimilar, but also looking at some of the commercial challenges and the reasons why we don’t see fast ramps, and we don’t see as much physician adoption as we probably should given the rigorous process that these products go through and the value that they have the potential to deliver.
Q&A With Dr Chelsee Jensen: Navigating FDA Approvals, Challenges in the Biosimilar Landscape
January 14th 2024Chelsee Jensen, PharmD, BCPS, senior pharmacy specialist and pharmaceutical formulary manager at Mayo Clinic, reacts to the biggest FDA approvals of 2023 and how she sees the adalimumab, natalizumab, and tocilizumab spaces playing out.
Biosimilars in America: Overcoming Barriers and Maximizing Impact
July 21st 2024Join us as we explore the complexities of the US biosimilars market, discussing legislative influences, payer and provider adoption factors, and strategies to overcome industry challenges with expert insights from Kyle Noonan, PharmD, MS, value & access strategy manager at Cencora.
IGBA 2023: Dr Monique Mansoura Highlights the Intersection of Geopolitical Issues, Biopharma
February 19th 2023COVID-19 allowed governments to critically examine the biopharma space to increase access to vaccines, but there's still a way to go, according to Monique Mansoura, PhD, MBA, executive director of global health security and biotechnology at the MITRE Corporation, at the International Generic and Biosimilar Medicines Association’s annual meeting.
Breaking Barriers in Osteoporosis Care: New Denosumab Biosimilars Wyost, Jubbonti Approved
June 16th 2024In this episode, The Center for Biosimilars® delves into the FDA approval of the first denosumab biosimilars, Wyost and Jubbonti (denosumab-bbdz), and discuss their potential to revolutionize osteoporosis treatment with expert insights from 2 rheumatologists.
