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.
Functional Similarity Between Ustekinumab Biosimilar ABP 654, Stelara in Crohn Disease
January 18th 2025Functional similarity of the ustekinumab biosimilar ABP 654 (Wezlana) and the reference product (Stelara) was confirmed by a series of in vitro studies, which support the totality of evidence for the biosimliar's FDA approval.
Biosimilars Gastroenterology Roundup for November 2024—Podcast Edition
December 1st 2024On this episode of Not So Different, we discuss market changes in the adalimumab space; calls for PBM transparency and biosimilar access reforms grew; new data for biosimilars in gastroenterology conditions; and all the takeaways from this year's Global Biosimilars Week.
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.
Top 5 Most-Read Rheumatology Articles of 2024
December 30th 2024The top 5 rheumatology biosimilar articles of 2024 highlight significant FDA approvals, including high-concentration adalimumab and tocilizumab biosimilars, along with evidence supporting the safety and efficacy of biosimilar-to-biosimilar switching.