On 29 July 2026, Biocon announced that it has received Notice of Compliance (NOC) approval from Health Canada for ustekinumab (Yesintek®), biosimilar to Janssen’s Stelara®, in an autoinjector pen format (45 mg/0.05mL and 90 mg/mL).
Yesintek® was first approved in Canada in October 2025 in the following formulations: solution for subcutaneous injection, 45 mg/0.5mL (prefilled syringe and vial) and 90 mg/mL (prefilled syringe); and solution for intravenous infusion, 130 mg/26mL (5 mg/mL). The product was launched in Canada in the same month.
On 29 August 2024, Biocon announced that it signed a patent settlement and licence agreement with Janssen for Canada, Japan, Europe and the UK. 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.
Other ustekinumab biosimilars approved and launched in Canada to date, include 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, with an autoinjector form approved in March 2026), Fresenius’ Otulfi® (approved January 2025, launched May 2025), Samsung Bioepis’ Pyzchiva™ (approved August 2024, 2026 launch planned) and Dong-A ST/Intas’ Imuldosa™ (approved January 2026, not yet launched).