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Alexandra Valenti, JD: Experience With BPCIA Litigation
Alexandra Valenti, JD, associate at Goodwin, discusses how Biologics Price Competition and Innovation Act (BPCIA) litigation has evolved with greater experience.
Transcript
So, [Biologics Price Competition and Innovation Act, BPCIA] litigation, I wouldn’t say it’s gotten any smoother. Some fundamental questions about how to interpret the statute have now been answered by the federal circuit and the Supreme Court, which certainly leaves fewer unanswered questions that can come up in a district court case.
However, these cases are still very complex. They involve many patents, many more patents than are typical in small-molecule Hatch-Waxman cases, and that has, attendant to it, further complexities in the case. There are usually more experts involved in these cases. The sheer volume of these patents just leads to more proceedings and takes longer to resolve.
And so, these cases are typically taking much longer than we saw on average in the Hatch-Waxman space. So, I wouldn’t say they’re going any smoother or less smooth, but certainly remain very complex litigations to undertake.
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.
