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Elaine Blais, JD: The FDA and Communications About Biosimilars
Elaine Blais, JD, partner at Goodwin and head of the litigation department in Goodwin’s Boston office, discusses what power the FDA has to regulate communications about biosimilars made by innovator drug companies.
Transcript:
The FDA has some power to regulate communications about biosimilars that might be made by branded companies, and they get that power from their power to regulate advertising in this space. We’ve seen citizen petition by folks like Pfizer asking FDA to get involved in managing the communications around the safety and efficacy of biosimilars. Hard to tell yet what FDA will do about that.
We know from the legislative fight around the [Biologics Price Competition and Innovation Act, BPCIA] that FDA really wants to stay out of litigation, and it may be the case of what we end up with seeing is the [Federal Trade Commission, FTC] or the [Department of Justice, DOJ] getting involved as we’ve seen in the Hatch-Waxman space, where there are examples of companies who have made significant misrepresentations about their product versus prior products or generic versions of their product, and have seen themselves faced with numerous litigations filed by a state attorney general, the FTC, the DOJ, the plaintiff’s bar, and competitors and the like. We may see that before we see FDA do much.
Can Global Policies to Boost Biosimilar Adoption Work in the US?
November 17th 2024On this special episode of Not So Different honoring Global Biosimilars Week, Craig Burton, executive director of the Biosimilars Council, explores how global policies—from incentives to health equity strategies—could boost biosimilar adoption in the US.
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: 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.
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.
