Biocon Biologics Gains Health Canada Approval for Yesintek™ (Ustekinumab) Biosimilar to Treat Psoriasis and Autoimmune Conditions

Biocon Biologics Ltd (BBL), a global biosimilars company, announced that it received a Notice of Compliance (NOC) from Health Canada for its ustekinumab biosimilar, Yesintek™.

Approved Products: Yesintek™ (ustekinumab injection) and Yesintek™ I.V. (ustekinumab for injection, solution for intravenous infusion).
Reference Product: Biosimilar to Stelara® and Stelara® I.V. (manufactured by Janssen/J&J).
Approval Date: The approval was granted on October 17, 2025.
Commercial Availability: The product is expected to be commercially available in Canada in mid-October (likely mid-October 2025, following the approval date).

Indications and Clinical Data

Yesintek™ is indicated for the treatment of a range of debilitating autoimmune conditions, mirroring the uses of the reference product:

Moderate to severe plaque psoriasis in adult and pediatric patients (6-17 years of age).
Active psoriatic arthritis in adults.
Moderately to severely active Crohn’s disease in adults.
Ulcerative colitis in adults.

The approval was based on a comprehensive data package, including results from the Phase 3 STELLAR-2 study, which confirmed no clinically meaningful differences between Yesintek™ and Stelara® in terms of pharmacokinetics, efficacy, safety, and immunogenicity.

Mechanism of Action: Ustekinumab is a fully human IgG1$\kappa$ monoclonal antibody that is a first-in-class agent. It works by binding specifically to the shared p40 protein subunit of human cytokines interleukin IL-12 and IL-23, which are key mediators of immune-mediated diseases.

Dosage and Formulation

Yesintek™ is available in two formulations:

Subcutaneous Injection (Yesintek™): Available as 45 mg/0.5ml (prefilled syringe and vial) and 90 mg/ml (prefilled syringe).
Intravenous Solution (Yesintek™ I.V.): Available as 130 mg/26mL (5mg/mL).

Impact and Commitment

Shreehas Tambe, CEO & Managing Director of Biocon Biologics, stated that this approval is a significant milestone that strengthens BBL’s presence in North America and enhances its immunology portfolio by providing a more affordable treatment option for Canadian patients.

Ramy Ayad, Head of Canada at Biocon Biologics, emphasized the company’s commitment to advancing biosimilar adoption in Canada to improve patient outcomes and deliver meaningful savings to the healthcare ecosystem through expanded access in both public and private markets.