Johnson & Johnson Sues Samsung Bioepis Over Alleged Biosimilar Agreement Breach For Its Flagship Psoriasis Drug

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Janssen authorized Samsung to sell Pyzchiva, a Stelara biosimilar, in the U.S. starting February 22, 2025, under a settlement agreement.
Janssen alleges Samsung breached the agreement by secretly authorizing a third party to launch a private label.
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Johnson & Johnson's JNJ Janssen Biotech has filed a lawsuit against Samsung Bioepis, alleging the company violated a settlement agreement regarding selling a biosimilar version of Stelara, a widely used treatment for autoimmune diseases.

Janssen claims Samsung's actions could unfairly disrupt competition and diminish Stelara's market share.

Also Read: Medicare Costs For Johnson & Johnson's Psoriasis Drug Stelara Double When Obtained at Pharmacies

Stelara (ustekinumab) is indicated for moderate to severe psoriasis, active psoriatic arthritis, Crohn's disease, and ulcerative colitis.

Janssen had previously reached agreements allowing competitors to introduce biosimilar versions under specific conditions. As part of one such settlement, Samsung was authorized to sell its biosimilar, Pyzchiva, in the U.S. beginning February 22, 2025.

However, Janssen alleges that in December 2024, Samsung disclosed its intent to authorize an additional private-label biosimilar through a third-party company without Janssen's approval, violating their agreement.

Endpoints published a copy of the lawsuit online Tuesday. The lawsuit asserts that this move could allow the third party—a major healthcare conglomerate with a vertically integrated system, including an insurance company, pharmacy chains, and a pharmacy benefits manager—to favor its private label biosimilar over Stelara.

Janssen argues this could lead to an unfair competitive advantage by steering prescriptions away from Stelara and other authorized biosimilars.

Janssen contends that Samsung intentionally concealed aspects of its agreement with the third party, further complicating the situation.

The lawsuit states that despite multiple warnings from Janssen, Samsung failed to justify its actions and refused to offer assurances that it would not proceed with the private label launch.

In August, Johnson & Johnson announced that it would implement significant changes to offering 340B pricing for its popular drugs, Stelara and Xarelto.

Price Action: JNJ stock is down 1.75% at $163.19 at the last check Wednesday.

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