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Imron Aly, JD: Key Trends in BPCIA Litigation
Imron Aly, JD, partner at Schiff Hardin, LLP, discusses key trends emerging in Biologics Price Competition and Innovation Act (BPCIA) litigation.
Transcript:
In our growing experience with the Biologics Price Competition and Innovation Act, are there some trends that you’ve seen emerging?
Yes, there are. The key trend is that there’s no need to go through a regulatory pathway, to first go through the FDA, and then go through the litigation at the district court level. So, what we’ve seen over and over is an opportunity to identify patents of interest, and then go to court on declaratory judgement actions right away. That’s the way to get to the market sooner and at least get the patent issues resolved—perhaps before investing the millions of dollars required for the regulatory side.
How Vertical Integration Drives Innovation and Access in Biosimilars
December 27th 2024Elie Bahou, PharmD, highlights how vertical integration in the biosimilar industry streamlines costs, improves supply reliability, accelerates market adoption, and enhances patient access, while emphasizing the value of collaboration, quality control, and value-based contracts for sustainable health care delivery.
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.
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.
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.
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.
