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Imron Aly, JD: Hatch-Waxman and BPCIA Litigation
Imron Aly, JD, partner at Schiff Hardin, LLP, explains how lessons learned from Hatch-Waxman proceedings can be applied to Biologics Price Competition and Innovation Act (BPCIA) litigation.
Transcript:
Are there lessons learned from Hatch-Waxman proceedings that you think can be applied to Biologics Price Competition and Innovation Act [BPCIA] litigation?
Yes—I would say that the BPCIA litigation is Hatch-Waxman on steroids. The reason I can say that is because we’re seeing a lot of brand-versus-brand interactions. Amgen, Pfizer…they all want to get into the biosimilars game, when in historical times, not so long ago, they were all making brand drugs, trying to stave off competition.
So what you’re going to now see is a lot of emerging trends about any ideas people had at Hatch-Waxman, where, from a generic company point of view, they’d have to pick and choose to prioritize specific arguments to fit within tighter budgets, now, on a brand-versus-brand larger scale, we can leave no stone unturned and be able to investigate a lot of issues and really dig down into the dip issues of invalidity, prior sale, prior use, anything that goes to invalidating those prior patents in the biosimilars world.
And those are things that are from the Hatch-Waxman space, but carried over really to a further extent on the biosimilars side.
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.
Eye on Pharma: Aflibercept Legal Drama; PBM, Humira Biosimilars; Denosumab Regulatory Review
October 15th 2024Regeneron appeals legal decision after judge refuses to block an aflibercept biosimilar; Prime Therapeutics, a pharmacy benefit manager (PBM), becomes the latest to offer biosimilars referencing Humira (adalimumab) at a low cost; the FDA and European Medicines Agency accept a denosumab biosimilar candidate for review.
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.
Patent Dance Insights: A Q&A on Reducing Legal Battles in the Biosimilar Landscape
August 18th 2024In an interview, Ha Kung Wong, an intellectual property attorney, explained that the Biologics Price Competition and Innovation Act of 2009 provides a structured but optional "patent dance" for biosimilars, which helps streamline patent disputes, potentially reducing litigation and encouraging early settlements.
Eye on Pharma: Canadian Aflibercept Settlement; Sandoz Acquires Cimerli; Payer Chooses Cyltezo
March 6th 2024Biocon Biologics settled with the maker of Eylea (aflibercept), announcing a launch date for its biosimilar competitor in Canada; Sandoz has officially acquired Cimerli, a ranibizumab biosimilar; AARP Medicare Rx from United Healthcare has added Cyltezo (adalimumab-adbm) and removed the originator (Humira) from its formulary.
