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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.
How Vertical Integration Drives Innovation and Access in Biosimilars
December 27th 2024Elie Bahou, PharmD, highlights how vertical integration in the biosimilar industry streamlines costs, improves supply reliability, accelerates market adoption, and enhances patient access, while emphasizing the value of collaboration, quality control, and value-based contracts for sustainable health care delivery.
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.
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.
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.
Q&A: Dr Kimberly Maxfield Explains How BsUFA III Will Advance the US Biosimilar Industry
December 20th 2023At AMCP Nexus, Kimberly Maxfield, PhD, pharmacologist at the FDA, delved into how the third reauthorization of the Biosimilar User Fee Act (BsUFA III) will shape the American biosimilar market and improve development efficiency over the next few years.
