Biocon Biologics Gets Health Canada Nod for Yesintek, a Biosimilar to Stelara
Bengaluru: Biocon Biologics Ltd (BBL), a subsidiary of Biocon Ltd, has 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), biosimilars to Stelara (ustekinumab injection) and Stelara I.V.
The approval, granted on October 17, 2025, clears the path for commercial availability in mid-October across Canada.
YESINTEK and YESINTEK I.V. are indicated for the treatment of moderate to severe plaque psoriasis in adults and pediatric patients (6–17 years), active psoriatic arthritis in adults, and moderately to severely active Crohn’s disease and ulcerative colitis in adults — autoimmune diseases affecting thousands of Canadians.
Health Canada’s decision 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. The drug will be accessible through the My Biocon Biologics™ patient support program, which assists patients prescribed with Biocon therapies.
Yesintek will be available as a subcutaneous injection (45 mg/0.5 mL prefilled syringe and vial; 90 mg/mL prefilled syringe), while Yesintek I.V. will be available as an intravenous solution (130 mg/26 mL, 5 mg/mL).
Shreehas Tambe, CEO & Managing Director of Biocon Biologics, stated:
“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, added:
“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.”
The company noted that Yesintek demonstrated no clinically meaningful differences from Stelara in the Phase 3 STELLAR-2 study, confirming comparable pharmacokinetics, efficacy, safety, and immunogenicity.
Biocon Biologics highlighted the important safety information, including contraindications in cases of hypersensitivity, severe infections such as sepsis or tuberculosis, and warnings regarding malignancy risk, infection monitoring, and vaccination precautions.
Yesintek (ustekinumab injection) and Yesintek I.V. (ustekinumab for injection) are biosimilars to Stelara, a fully human IgG1κ monoclonal antibody that binds specifically to the shared p40 protein subunit of human cytokines IL-12 and IL-23, which are linked to immune-mediated diseases.
Biocon Biologics Ltd, a subsidiary of Biocon Limited, is a global, fully integrated biosimilars company serving over 6 million patients across more than 120 countries. The company has commercialized 10 biosimilars globally and has a pipeline of 20 assets spanning diabetology, oncology, immunology, ophthalmology, and bone health.
