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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.
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.
