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"Not So Different": Goodwin Attorneys Give a Look at Biosimilar Litigation
In the past decade of experience with the Biologics Price Competition and Innovation Act, a number of questions about the biosimilar pathway have been resolved through litigation. This week on the podcast, we're speaking with attorneys Robert Cerwinski, JD, and Alexandra Valenti, JD, both of whom are partners at Goodwin, about experience with litigation, the road ahead for biosimilars, and Goodwin's recently published guide to biosimilar litigation.
In the past decade of experience with the the Biologics Price Competition and Innovation Act, a number of questions about the biosimilar pathway have been resolved through litigation. This week on the podcast, we're speaking with attorneys Robert Cerwinski, JD, and Alexandra Valenti, JD, both of whom are partners at Goodwin, about experience with litigation, the road ahead for biosimilars, and Goodwin's recently published guide to biosimilars litigation.
To learn more about the Guide to Biosimilars Litigation and Regulation in the US, visit the purchase page here.
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 Development Roundup for October 2024—Podcast Edition
November 3rd 2024On this episode of Not So Different, we discuss the GRx+Biosims conference, which included discussions on data transparency, artificial intelligence (AI), and collaboration to enhance the global supply chain for biosimilars and generic drugs, as well as the evolving requirements for biosimilar devices.
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.
Biosimilars Policy Roundup for September 2024—Podcast Edition
October 6th 2024On this episode of Not So Different, we discuss the FDA's approval of a new biosimilar for treating retinal conditions, which took place in September 2024 alongside other major industry developments, including ongoing legal disputes and broader trends in market dynamics and regulatory challenges.
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.
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.
