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Alexandra Valenti, JD: Common Features of Lawsuits Filed Against AbbVie Over Humira
Alexandra Valenti, JD, associate at Goodwin, discusses common features of some recent high-profile class-action lawsuits over AbbVie’s Humira.
Transcript
So, the cases typically allege antitrust violations based on 2 features of what’s happened with AbbVie’s Humira adalimumab product. The first is AbbVie’s acquiring a very large patent estate covering that product. Well over 100 patents covering the 1 product. There’s allegations that those patents are very similar to each other, have overlapping claims, and lead to a kind of improper monopoly over the adalimumab Humira product.
The other piece is the settlement agreements that we’ve mentioned a couple of times already. AbbVie has settled with 8 different biosimilar manufacturers concerning their adalimumab products. And under those agreements, most of those products are already available in the European Market but won’t enter the US market until a staggered set of dates in 2023, and so the antitrust allegations are based on that state of affairs, alleging that AbbVie has improperly kind of orchestrated the biosimilar competition and staged it in such a way that biosimilar competition won’t enter the market until much [later] than it would have otherwise.
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.
