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.
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.
Patient-Reported Outcomes Similar Between Adalimumab-adbm, Reference Product in VOLTAIRE-RA Study
September 28th 2024A summary of research written by Vibeke Strand, MD, clinical professor in division of immunology/rheumatology at Stanford University School of Medicine, gave an overview of patient-reported outcomes (PROs) in the VOLTAIRE-RA trial.
Expanding Biosimilar Adoption: Insights and Strategies With Dr Sophia Humphreys
September 16th 2024Sophia Humphreys, PharmD, MHA, BCBBS, director of system formulary management at Sutter Health, discusses the challenges of expanding biosimilars into new therapeutic areas and highlights the role of education, competitive pricing, and integrated delivery networks in improving adoption and market growth.
Real-World Study Shows Comparable Outcomes Between CT-P13, Remicade in RA
September 14th 2024A real-world study of the biosimilar infliximab-dyyb (CT-P13; Inflectra) in rheumatoid arthritis (RA) reported the majority of patients who initiated CT-P13 switched from the reference product (Remicade) or another biologic or targeted synthetic disease-modifying antirheumatic drug.