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Scott Gottlieb, MD: Improving the US Biosimilars Market
Scott Gottlieb, MD, former commissioner of the FDA, discusses how to improve the US biosimilars market.
Transcript
I think continuing to try to make it efficient for biosimilars to get claims of interchangeability will help make the products ultimately more competitive. That process, doing the switching studies to get an interchangeability claim, is fairly efficient, but I think there’s things that you can continue to look at in terms of using real-world evidence and looking at how you structure those switching studies to potentially make it more efficient.
Sometimes those studies are hard to enroll because doctors don't want to enroll patients and patients don't want to enroll in those kinds of studies. So, we do need to continue to look at that, but again, I don’t think that is the biggest impediment if you will, or is going to provide the biggest benefit in terms of trying to foster more competition. I think that the greatest changes that we can make are really going to be on the commercial side.
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.
