J&J sues Samsung Bioepis over contract breach for Stelara biosimilar

Alvotech SA

24/02/2025 22:25

Feb 24 (Reuters) - Johnson & Johnson  JNJ.N  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  SDZ.S , 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  TEVA.TA  and Alvotech  ALVO.O  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.O  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.
    
      

 (Reporting by Sneha S K in Bengaluru; Editing by Alan Barona)
 ((Sneha.SK@thomsonreuters.com))