Johnson & Johnson Sues Samsung Bioepis Over Unauthorized Biosimilar Licensing of Stelara (Ustekinumab)

Recently, a重磅消息 rocked the pharmaceutical industry as Johnson & Johnson officially filed a lawsuit against Samsung Bioepis, accusing the company of breach of contract regarding the biosimilar version of ustekinumab. This event immediately drew significant attention both within and outside the industry.

Giants in Conflict: The Origin of Litigation

On February 24, 2025, Johnson & Johnson filed a lawsuit with the U.S. District Court for the District of New Jersey. It is reported that as early as 2023, Johnson & Johnson reached an agreement with Samsung Bioepis, allowing Samsung Bioepis to launch Pyz Chiva, a biosimilar of ustekinumab, in 2025. However, Johnson & Johnson discovered that Samsung Bioepis had entered into an unauthorized sublicense agreement with a private label supplier. Johnson & Johnson believes this action seriously violates their original agreement and damages its own rights, hence the lawsuit, requesting the court to issue a preliminary injunction.

Stelara: A Blockbuster in the Pharmaceutical Market

Stelara, with the generic name ustekinumab, was developed by Johnson & Johnson. In January 2009, it received its first approval in the European Union, and in November 2017, it entered the Chinese market under the brand name Stelara (喜达诺). As a monoclonal antibody targeting the shared p40 subunit of IL-12 and IL-23, it has demonstrated excellent efficacy in treating various autoimmune diseases. Its approved indications are extensive, covering moderate to severe plaque psoriasis in adults, adolescents, and children, active psoriatic arthritis in adults, moderately to severely active Crohn's disease, ulcerative colitis, and juvenile active psoriatic arthritis. With its significant therapeutic effects, Stelara has shown strong performance in the global market, achieving global sales of $10.361 billion in 2024, making it Johnson & Johnson’s "blockbuster product."

The Biosimilar Market: A Dynamic Landscape

The U.S. patent for ustekinumab expired in 2023, and its biosimilars face fierce competition. Currently, six ustekinumab biosimilars have been approved globally. In addition to Samsung Bioepis' product, relevant products from Amgen, Alvotech, Celltrion, Formycon, and Dong-A Pharma have also entered the market. Amgen's Wezlana received approval from the U.S. Food and Drug Administration (FDA) on October 31, 2023, and can be used interchangeably with Stelara for treating various inflammatory diseases. On the same day Johnson & Johnson sued Samsung Bioepis, Teva Pharmaceuticals and Alvotech launched Selars Di, a biosimilar of Stelara, offering a 15% discount, further intensifying the market competition.

In China, Huadong Medicine's ustekinumab biosimilar HDM3001 was approved for marketing in October 2024, becoming the first domestically produced ustekinumab biosimilar. On February 11, 2025, its marketing authorization application and supplementary application for Crohn's disease were also accepted by the National Medical Products Administration.

The lawsuit filed by Johnson & Johnson against Samsung Bioepis for breach of contract not only concerns the interests of the two companies but also will have an impact on the entireUstekinumabThe competitive landscape of the biosimilar market will have a profound impact. What follows: an out-of-court settlement or a showdown in court?UstekinumabHow will the biosimilar market develop? We will continue to monitor and bring you the latest updates.