Biocon Biologics gets Health Canada approval for Yesintek, Yesintek I.V.

The approval of Yesintek and Yesintek I.V., biosimilars to Stelara, strengthens Biocon Biologics' presence in North America and expands its immunology portfolio

Biocon Biologics (BBL), a subsidiary of Biocon, has received Health Canada approval for Yesintek (ustekinumab injection) and Yesintek I.V. (ustekinumab for injection, solution for intravenous infusion), a biosimilar to Stelara and Stelara I.V. The Notice of Compliance was granted on October 17, 2025, allowing for commercial availability in Canada from mid-October.

 

Yesintek approved for multiple autoimmune indications

 

The biosimilars are indicated for moderate to severe plaque psoriasis in adults and paediatric patients (6–17 years), active psoriatic arthritis in adults, and moderately to severely active Crohn’s disease and ulcerative colitis in adults. Health Canada’s approval is based on data demonstrating no clinically meaningful differences in efficacy, safety or immunogenicity compared with Stelara.

 

 

Yesintek will be available as a subcutaneous injection in 45 mg/0.5 ml (prefilled syringe and vial) and 90 mg/ml (prefilled syringe), while Yesintek I.V. will be supplied as an intravenous solution, 130 mg/26 ml (5 mg/ml). The therapy will be offered through the My Biocon Biologics patient support programme, which provides access support for prescribed patients. 

 

Approval strengthens Biocon Biologics’ North American presence

 

Shreehas Tambe, Chief Executive Officer and Managing Director, Biocon Biologics, said: “Building on our successful US 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 bringing 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.”

 

Company expands global biosimilars pipeline

 

Biocon Biologics has previously commercialised 10 biosimilars and maintains a pipeline of 20 biosimilar assets across areas including diabetology, oncology, immunology, ophthalmology and bone health. The company has commercial operations in over 120 countries and is active in both emerging and advanced markets.