On 29 February 2024, Biocon Biologics Ltd, announced a settlement with J&J and Janssen, under which it can launch its Bmab 1200 (ustekinumab), biosimilar to Janssen’s Stelara®, in the USA from February 2025. The FDA previously accepted for review Biocon’s Biologics License Application for Bmab 1200.
The settlement will result in the termination of the pending Inter Partes Review petition filed by Biocon in November 2023 against Janssen’s US method of treatment (severely active ulcerative colitis (UC)) patent 10,961,307 relating to Stelara® (ustekinumab).
J&J and Janssen recently entered into ustekinumab settlements with Alvotech (launch dates of no later than 21 February 2025 (US), May 2024 (Japan), late July 2024 (EU) and Q1 2024 (Canada)), BioPharma (US launch date of 15 May 2025), Samsung Bioepis (US launch date from 22 February 2025), Celltrion (US launch date of 7 March 2025), Fresenius Kabi and Formycon (US launch date no later than 15 April 2025), and Amgen (US launch date no later than 1 January 2025). To date, only Amgen has obtained FDA approval for its ustekinumab biosimilar, with its Wezlana® approved in October 2023.