Key 2020-2021 updates to the Guide to Biosimilars litigation and Regulation in the US encompass antitrust litigation, preliminary injunctions, and a slowdown in litigation.
Before the battle for market share gets started, the courtroom is the OK Corral for biosimilar developers and reference product manufacturers, who duke it out over patents to determine how soon biosimilars can enter the marketplace. We spoke with Alexandra Valenti, JD, and Rob Cerwinski, JD, Goodwin partners and senior editors of the updated Guide to Biosimilars Litigation and Regulation in the US about some of the key developments.
To learn more about Valenti and Cerwinski's updated guide, click here.
To learn more about adalimumab patent disputes, click here.
To learn more about the future state for the adalimumab market, click here.
To take our quiz on adalimumab, click here.
Julie Reed: Why 2024 Is Important for Biosimilars
April 17th 2024Julie Reed, executive director of the Biosimilars Forum, showcases how the biosimilar industry is expected to develop throughout 2024, including major policy changes and hope for continued improvement in market share for adalimumab biosimilars.
Alvotech’s Stelara Biosimilar, Selarsdi, Receives FDA Approval
April 16th 2024Alvotech’s Selarsdi (ustekinumab-aekn), a biosimilar referencing Stelara (ustekinumab), gained FDA approval, making it the second ustekinumab biosimilar and second for the company to be given the green light for the American market.
Decoding the Patent Puzzle: Navigating the Legal Landscape of Biosimilars
March 17th 2024On this episode of Not So Different, Ha Kung Wong, JD, an intellectual patent attorney and partner at Venable LLP, details the confusing landscape that is the US patent system and how it can be improved to help companies overcome barriers to biosimilar competition.
Meta-Analysis Confirms Similar Safety, Efficacy Between Adalimumab Biosimilars, Humira
April 6th 2024A systematic review and meta-analysis of 7 randomized controlled trials found no significant differences in efficacy and safety indicators between adalimumab biosimilars and the reference product (Humira) for treatment of moderate to severe psoriasis.