On 7 January 2025, Biocon announced that Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has approved its subcutaneous ustekinumab (Bmab 1200), biosimilar to J&J/Janssen’s Stelara®. Biocon’s biosimilar ustekinumab will be commercialised and marketed in Japan by its exclusive commercial partner, Yoshindo Inc.
This news follows Biocon’s announcement on 15 December 2024 that Europe’s CHMP issued a positive opinion recommending approval of its ustekinumab biosimilar (Yesintek®), for treatment of plaque psoriasis treatment of adults and children with plaque psoriasis and adults with psoriatic arthritis or Crohn’s disease.
Yesintek® received FDA approval in early December 2024 for the treatment of Crohn’s disease, ulcerative colitis, plaque psoriasis and psoriatic arthritis. Biocon can launch Yesintek® in the US in February 2025 as agreed in a settlement deal between Biocon and J&J entered in February 2024.
On 29 August 2024, Biocon announced that it signed a patent settlement and licence agreement with Janssen which enables Biocon to commercialise Bmab 1200/Yesintek® in Europe, the United Kingdom, Canada and Japan. The agreed launch dates for these jurisdictions remain confidential.
The first ustekinumab biosimilar to be approved in Japan was reportedly Alvotech/Fuji Pharma’s AVT04, in September 2023.