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J&J sues Samsung Bioepis over contract breach for Stelara biosimilar
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J&J sues Samsung Bioepis over contract breach for Stelara biosimilar
Feb 24, 2025 2:57 PM

(Reuters) - Johnson & Johnson ( JNJ ) said on Monday it had filed a lawsuit against Samsung Bioepis for breaching its contract agreement with the drugmaker over the launch of a biosimilar to Stelara, J&J's autoimmune drug.

J&J said it is seeking a preliminary injunction for Samsung Bioepis' close copy of Stelara over an unauthorized sublicense deal with a private label provider, which the drugmaker declined to identify.

The company, along with partner Sandoz, said earlier on Monday that its biosimilar Pyzchiva is now available in the United States.

J&J over the past two years has signed settlement agreements with several companies to delay the U.S. launches of Stelara, its top-selling drug since 2019.

Close copies of Stelara launched in Europe, Canada and a few other markets last year and at least six close copies of Stelara are expected to launch in the U.S. this year.

Teva Pharmaceuticals and Alvotech ( ALVO ) last Friday launched Selarsdi, a biosimilar to Stelara. The U.S. Food and Drug Administration has allowed the use of Selarsdi as an "interchangeable" substitute only after April 30, when the exclusive rights for Amgen's ( AMGN ) Wezlana expire.

Pyzchiva is approved to treat moderate to severe plaque psoriasis, active psoriatic arthritis, moderately to severely active Crohn's disease and moderately to severely active ulcerative colitis.

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