Health Canada grants NOC for Biocon Biologics’ Yesintek and Yesintek I.V

Biocon Biologics, a fully integrated global biosimilars company and subsidiary of Biocon, announced that Health Canada has granted a Notice of Compliance (NOC) for Yesintek (ustekinumab injection) and Yesintek I.V. (ustekinumab for injection, solution for intravenous infusion). The approval, granted on 17 October 2025, allows for Canadian commercial availability in mid-October.

Yesintek and Yesintek I.V. are biosimilars to Stelara® (ustekinumab injection) and Stelara® I.V. (ustekinumab for injection, solution for intravenous infusion). They are indicated for the treatment of moderate to severe plaque psoriasis in adults and pediatric patients aged 6–17 years, active psoriatic arthritis in adults, and moderately to severely active Crohn’s disease and ulcerative colitis in adults.

Health Canada approval was based on a comprehensive data package confirming that Yesintek is highly similar to Stelara® with no clinically meaningful differences in efficacy, safety, or immunogenicity. Yesintek will be available through the My Biocon Biologics patient support program. Yesintek is supplied as a subcutaneous injection, 45 mg/0.5 mL (prefilled syringe and vial) and 90 mg/mL (prefilled syringe). Yesintek I.V. is supplied as an intravenous solution, 130 mg/26 mL (5 mg/mL).

Shreehas Tambe, CEO & Managing Director, Biocon Biologics, said: “Health Canada’s approval of Yesintek marks a significant milestone in our mission to expand global access to high-quality biosimilars. Building on our successful U.S. launch, this approval strengthens our presence in North America and enhances our immunology portfolio with a more affordable treatment option for Canadian patients living with chronic autoimmune conditions.”

Ramy Ayad, Head of Canada at Biocon Biologics, said: “We are excited to bring Yesintek to Canadian patients, providing a trusted, value-driven ustekinumab biosimilar. Biocon Biologics is committed to advancing biosimilar adoption in Canada to improve outcomes for patients and deliver meaningful savings to the healthcare ecosystem. By expanding access in both public and private markets, we aim to help build a sustainable biosimilars industry that benefits all Canadians.”

About Yesintek

Yesintek and Yesintek I.V. are biosimilars to Stelara® and Stelara® I.V., a fully human IgG1κ monoclonal antibody that binds with specificity to the shared p40 protein subunit of interleukin IL-12 and IL-23 mediated signalling associated with immune-mediated diseases. The Phase 3 STELLAR-2 study showed no clinically meaningful differences between Yesintek and Stelara® in pharmacokinetics, efficacy, safety, and immunogenicity.

Important Safety Information

Contraindications: Hypersensitivity to Yesintek/Yesintek I.V. or any ingredient, and severe infections including sepsis, tuberculosis, or opportunistic infections.

Warnings and Precautions:

• Infections: Patients should be evaluated for tuberculosis before treatment. Do not administer Yesintek to patients with clinically important active infections. Monitor for signs of infection during and after treatment.
• Malignancy: Potential increased risk of malignancy. Monitor for skin cancer, particularly in patients over 60, with prolonged immunosuppressant therapy, or prior PUVA treatment.
• Concomitant Immunosuppressive Therapy: Use caution when administered with other immunosuppressive agents or during transition from other biologics.
• Immunisation: Live vaccines should not be given concurrently. Non-live vaccines may not elicit sufficient response. For infants exposed in utero, wait six months before administering live vaccines unless benefits outweigh risks.
• Allergy Immunotherapy: Exercise caution in patients receiving or who have received allergy immunotherapy.
• Reversible Posterior Leukoencephalopathy Syndrome (RPLS): Monitor for neurological symptoms such as headache, seizures, confusion, and visual disturbances. Fatal outcomes have been reported.
• Hypersensitivity Reactions: Serious allergic reactions, including anaphylaxis and angioedema, have been reported. Rare cases of allergic alveolitis and eosinophilic pneumonia have also occurred.

Women of Childbearing Potential: Use effective contraception during treatment and for at least 15 weeks after last dose. Preconception counselling is recommended.