On 18 February 2025, Biocon Biologics announced that the European Commission has granted marketing authorisation for Yesintek®, biosimilar to J&J/Janssen’s Stelara® (ustekinumab). Yesintek® is indicated for the treatment of adults and children with plaque psoriasis and treatment of adults with psoriatic arthritis and Crohn’s disease. The marketing authorisation approval follows a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) on 14 December 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.
There are a number of ustekinumab biosimilars being marketed in the EU, with three launched during 2024, STADA/Alvotech’s Uzpruvo® and Sandoz’s Pyzchiva® in July 2024, and Celltrion’s SteQeyma® in November 2024. Previously approved ustekinumab biosimilars in Europe include Formycon/Fresenius’ Otulfi®/FYB202 (September 2024), Samsung Bioepis’ Eksunbi™ (September 2024) and Amgen’s Wezenla™ (June 2024). Bio-Thera’s MAA for BAT2206 (ustekinumab) was also accepted by the EMA in July 2024.
Yesintek® was approved in the US in early December 2024 for the treatment of Crohn’s disease, ulcerative colitis, plaque psoriasis and psoriatic arthritis. In January 2025, Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) approved Biocon’s subcutaneous ustekinumab (Bmab 1200).
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.