J&J sues Samsung Bioepis over contract breach for Stelara biosimilar
Johnson & Johnson filed a lawsuit in a New Jersey federal court, against Samsung Bioepis for breaching its contract agreement with the company over the launch of a biosimilar to its autoimmune drug Stelara, per a Reuters report.
The report noted that 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 J&J declined to identify, per the report.
The suit seeks a preliminary injunction to bar U.S. sales of the private-label version of Samsung Bioepis' Stelara biosimilar, called Pyzchiva.
Samsung and J&J signed a settlement agreement in July 2023 allowing for the launch of Pyzchiva this month.
J&J, and its partner Sandoz said earlier on Monday that its biosimilar Pyzchiva is now available in the United States.
J&J in the lawsuit claimed that the agreement did not permit Samsung to introduce an additional private label drug at the expense of J&J market share and fair competition. It also requested a permanent injunction and financial damages as part of its lawsuit, the Reuters report said.
[Read more: FDA gives Biocon Biologics approval for Stelara biosimilar]
Over the past two years, J&J has signed settlement agreements with several companies to delay the U.S. launches of Stelara biosimilars, the report said, noting that 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 United States this year, the report said.
Teva Pharmaceuticals and Alvotech last Friday launched Selarsdi, a biosimilar to Stelara. The 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 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.
[Read more; Evernorth to offer Stelara biosimilar at $0 out of pocket for patients early next year]