On 23 October 2025, Biocon Biologics announced that Health Canada has approved Biocon’s Yesintek™ and Yesintek™ IV (intravenous), biosimilars to Janssen’s Stelara® (ustekinumab), for moderate to severe plaque psoriasis, active psoriatic arthritis, moderately to severely active Crohn’s disease and ulcerative colitis.
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 Canada, Japan (approved January 2025), Europe (approved February 2025) and the United Kingdom (approved May 2025) from an unknown date. Yesintek® was approved in the US in early December 2024, and was subsequently launched in February 2025, following a US settlement entered in February 2024.
A number of other ustekinumab biosimilars have been approved and launched in Canada to date, including JAMP/Alvotech’s Jamteki® (approved November 2023, launched March 2024), Amgen’s Wezlana® (approved December 2023, launched March 2024), Celltrion’s Steqeyma® (approved July 2024, launched August 2024), Samsung Bioepis’ Pyzchiva™ (approved August 2024, not yet launched) and Fresenius’ Otulfi® (approved December 2024, launched May 2025).