Biosimilar Battle: J&J Sues Samsung Over Stelara Market Intrusion

Johnson & Johnson filed a lawsuit against Samsung Bioepis for allegedly breaching their agreement over the launch of Stelara's biosimilar, Pyzchiva. J&J seeks to prevent its U.S. sales, claiming unauthorized sublicense dealing damaged J&J's market share. The legal tussle reflects potential market shifts similar to AbbVie's Humira.

Johnson & Johnson has initiated legal proceedings against Samsung Bioepis, accusing the company of violating a contract regarding the launch of Pyzchiva, a biosimilar to J&J's flagship psoriasis treatment, Stelara. The lawsuit, lodged in a New Jersey federal court, revolves around an alleged unauthorized sublicense agreement with an undisclosed private label provider.

J&J is seeking a preliminary injunction to halt U.S. sales of Pyzchiva, launched by Samsung and Sandoz. The suit alleges a breach of the settlement reached in July 2023, which permitted Pyzchiva's release this month but reportedly did not authorize introducing a private label version that could detriment J&J's market share.

Stelara's significant market presence, with 2024 sales surpassing $10 billion, is under threat as its patents have begun expiring. The legal confrontation echoes the market changes seen with AbbVie's Humira, as biosimilars challenge established drug dominance amidst sales strategies and competitive pressures.

(With inputs from agencies.)