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Scott Lassman: The FTC and Biosimilar Competition
Scott Lassman, JD, partner in Goodwin's Technology and Life Sciences Group, discusses the role that the Federal Trade Commission (FTC) may play in encouraging biosimilar competition.
Transcript:
Do you see any potential for regulatory agencies, such as the FTC, to weigh in on anti-competitive practices in the biologics and biosimilars world?
Absolutely. I can’t comment on whether they’re going to come in on a particular issue, but they’ve been very active in this area already. Years ago, when there were questions about the Hatch-Waxman Act and whether companies were abusing the patent listing process, they did a big study and actually commented to the FDA and spurred the FDA to change their regulations.
Most recently, they’ve been very active in the biosimilar and REMS area. There have been lawsuits by generic companies who could not get samples from the brand purportedly because the REMS prevented it. The FTC has come in with amicus briefs, they’ve come in with amicus briefs on some of the biosimilar issues, so they’ve actually been very, very active on this and I would expect that to continue in the future.
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.
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.
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.
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.
