Johnson & Johnson Sues Samsung Bioepis Over Alleged Stelara Biosimilar Contract Breach

Johnson & Johnson's Janssen Biotech has filed a lawsuit against Samsung Bioepis, alleging a violation of their settlement agreement regarding the sale of a biosimilar version of Stelara (ustekinumab)1.

The lawsuit claims that Samsung Bioepis intends to authorize an additional private-label biosimilar through a third-party company without Janssen's approval, which violates their agreement1.

Stelara is a widely used treatment for autoimmune diseases, including moderate to severe psoriasis, active psoriatic arthritis, Crohn's disease, and ulcerative colitis1.

The original agreement allowed Samsung Bioepis to sell its biosimilar, Pyzchiva, in the U.S. starting February 22, 20251.

Johnson & Johnson is seeking a preliminary and permanent injunction to block the launch of the private label product in the U.S.4.

The lawsuit alleges that Samsung Bioepis' actions could unfairly disrupt competition and diminish Stelara's market share1.

The undisclosed third party is described as a major healthcare conglomerate with a vertically integrated system, including an insurance company, pharmacy chains, and a pharmacy benefits manager1.

Samsung Bioepis and its partner Sandoz launched Pyzchiva in the U.S. on February 26, 20259.

This legal action raises questions about the implications for other biosimilar manufacturers and the broader biosimilar market3.

The biosimilar sector is projected to experience significant growth, with GlobalData forecasting an increase in biosimilar sales from 5.7% in 2022 to 18.3% in 2032 across major markets4.

Sources:

1. https://www.benzinga.com/25/02/43986614/johnson-johnson-sues-samsung-bioepis-over-alleged-biosimilar-agreement-breach-for-its-flagship-psoriasis-drug

3. https://biosimilarsrr.com/2025/02/26/what-the-jj-suit-against-samsung-bioepis-tells-us/

4. https://www.pharmaceutical-technology.com/news/jandj-sues-samsung-bioepis-over-surreptitious-breach-of-stelara-biosimilar-contract/

9. https://www.claimsjournal.com/news/national/2025/02/25/329135.htm