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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.
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: Celltrion, Costco Partnership; Amgen Sues Samsung Bioepis; Denosumab Results
August 21st 2024Celltrion's adalimumab-aaty biosimilar is now accessible for all Costco members, while Amgen sues Samsung Bioepis over the latter’s denosumab biosimilar candidate, and GlycoNex progresses its denosumab biosimilar SPD8 to phase 3 trials.
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.
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.
Eye on Pharma: VA Picks Hadlima; Biocon, Sandoz Partnership; A Stelara Settlement Abroad
February 21st 2024The US Department of Veterans Affairs (VA) has chosen to replace Humira (adalimumab) with Organon’s biosimilar version on its national formulary; Biocon Biologics and Sandoz announce a new partnership in Australia for 2 biosimilars; Alvotech settles with Johnson & Johnson over its biosimilar to Stelara (ustekinumab) for the European and Canadian markets.
