On 6 November 2025, Samsung Bioepis announced that it has signed a settlement and licence agreement with Johnson & Johnson (J&J) in relation to the European commercialisation of Pyzchiva® (SB17), biosimilar to Stelara® (ustekinumab).
While the terms of the agreement are confidential, the settlement is expected to resolve a pending Dutch Supreme Court appeal in relation to Janssen’s Supplementary Protection Certificate (SPC) for EP 1 309 692 B1 regarding ustekinumab. The appeal followed an April 2025 SPC Waiver ruling of the Hague Court of Appeal upholding an earlier decision that Samsung Bioepis did not infringe the SPC by manufacturing and stockpiling Pyzchiva® for export outside the European Union.
The parties have been involved in a number of disputes regarding the validity of Janssen’s European patents for ustekinumab, including EP 3883606, relating to the use of ustekinumab for treating ulcerative colitis. In September 2025, the District Court of The Hague held that the Dutch equivalent of the patent was valid. A year earlier, in September 2024, Justice Meade of the High Court of Justice of England and Wales refused Janssen leave to appeal from an earlier decision that the UK counterpart of the patent was invalid. Samsung Bioepis’ opposition to EP 3883606 in the European Patent Office was discontinued on 3 November 2025, after Samsung Bioepis formally withdrew it.
Pyzchiva® is commercialised by Sandoz in EEA, Switzerland, UK, US and Canada pursuant to a deal entered into in September 2023 between Sandoz and Samsung Bioepis. Pyzchiva® was approved by the European Commission in April 2024, and was launched by Sandoz in Europe in July 2024.
Samsung Bioepis and J&J settled US litigation regarding ustekinumab in 2023, permitting Samsung Bioepis/Sandoz to commercialise Pyzchiva® in the US in February 2025.