On 24 February 2025, Johnson & Johnson (J&J) and Janssen Biotech filed a complaint in the US District Court for the District of New Jersey alleging that Samsung Bioepis has breached a settlement and licence agreement entered in July 2023 (announced in November 2023), permitting Samsung Bioepis to launch Pyzchiva® (SB17) (ustekinumab), biosimilar to J&J/Janssen’s Stelara®, in the US from 22 February 2025. The settlement agreement resolved pending US patent litigation between the companies at the time it was signed.
The complaint, filed the same day on which the US launch of Pyzchiva® was announced, claims that Samsung Bioepis has entered into an unauthorised sublicence with a private label provider. While the private label provider has not been publicly identified, it is described in J&J’s complaint as a member of a vertically integrated health conglomerate that includes a health insurer, health care provider, pharmacy chain and pharmacy benefits manager (PBM). According to J&J, the 2023 settlement agreement did not permit Samsung Bioepis to authorise the private label provider to launch in the US an additional, private label version of Pyzchiva®.
J&J is seeking a preliminary injunction preventing US sales of the private label version of Samsung Bioepis’ ustekinumab biosimilar and compensatory damages “in an amount to be determined at trial”. Samsung Bioepis has not yet filed a defence.
Pyzchiva® was approved by the US FDA in July 2024 for multiple indications, including moderate to severe plaque psoriasis, active psoriatic arthritis and moderately to severely active Crohn’s disease and ulcerative colitis. It is commercialised in the US (and Europe and Canada) by Sandoz pursuant to a deal entered into in September 2023 between Sandoz and Samsung Bioepis.
J&J has previously entered into ustekinumab settlement agreements with Amgen (which launched its biosimilar, Wezlana®, in early January 2025 through Optum Health Solution’s private label subsidiary Nuvaila), Alvotech and Teva (Selarsdi® launched on 21 February 2025), Biocon (Yesintek™ launched on 24 February 2025), Celltrion (US licence date of 7 March 2025) and Fresenius Kabi and Formycon (US licence date no later than 15 April 2025).
Janssen and Samsung Bioepis remain in patent infringement litigation in Australia, with the trial scheduled in June 2025. In October 2024, the Canadian Federal Court dismissed a motion by Janssen to add an infringement counterclaim in proceedings brought by Samsung Bioepis to invalidate one of Janssen’s Canadian patents covering ustekinumab.