Samsung announced that has signed a settlement and licence agreement with Johnson & Johnson settling all pending US patent litigation between the companies, with a licence to Samsung to commercialise its Stelara (ustekinumab) biosimilar SB17 in the US from 22 February 2025.
Samsung and J&J subsidiary Janssen previously made reference to a settlement (without reference to the licence date) in their joint motion dated 3 August 2023, to terminate Samsung’s Inter Partes Review (IPR) challenging Janssen’s US patent 10 961 307.
Samsung’s BLA for SB17 is under review with the FDA and if approved will be commercialised in the US by Sandoz.
J&J has also entered into ustekinumab settlements with Celltrion (with a US licence date of 7 March 2025), Fresenius Kabi and Formycon (with a US licence date no later than 15 April 2025), Alvotech and Teva (with US licence date no later than 21 February 2025) and Amgen (with a US licence date no later than 1 January 2025).