- Biocon’s Canadian subsidiary received Health Canada Notice of Compliance (NOC) for Yesintek (ustekinumab) Autoinjector in 45 mg/0.5 mL and 90 mg/mL strengths, expanding its immunology portfolio. This follows the October 2025 approval of the prefilled syringe, vial, and IV infusion formulations.
- The Yesintek Autoinjector offers Canadian patients a self-injection option not available with the originator product, enabling more personalized treatment across different care settings and patient preferences.
- Yesintek is approved for moderate-to-severe plaque psoriasis in adults and children (6–17 years), active psoriatic arthritis, and moderately-to-severely active Crohn’s disease and ulcerative colitis in adults.
- The approval reinforces Biocon’s commitment to improving access to affordable biosimilars while strengthening its presence in Canada’s immunology market.
Takeaways:
The approval expands Biocon’s immunology footprint in Canada by rounding out the Yesintek portfolio with an autoinjector alongside the already-approved prefilled syringe, vial and IV formats, giving payers and providers more choice and reinforcing biosimilar competition in the ustekinumab class. This can strengthen uptake in psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis by offering a more convenient device for eligible patients, while supporting Biocon’s broader strategy of increasing access to affordable biologics and consolidating its position in Canada’s autoimmune market.
Source: Biocon
