Biocon Biologics Ltd (BBL), a fully integrated global biosimilars company and subsidiary of Biocon Ltd, 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® and Stelara® I.V. respectively. The approval, paves the way for commercial availability in Canada by mid-October, marking a significant step in Biocon Biologics’ mission to expand access to advanced biologic therapies across North America.
Expanding Access to Treatment for Autoimmune Disorders
Yesintek™ and Yesintek™ I.V. are approved for the treatment of several moderate to severe autoimmune diseases, including:
*Plaque psoriasis (adults and pediatric patients aged 6–17 years)
*Active psoriatic arthritis (adults)
*Moderately to severely active Crohn’s disease (adults)
*Ulcerative colitis (adults)
These chronic and often debilitating conditions affect thousands of Canadians. The arrival of an affordable biosimilar option is a welcome development for patients and healthcare providers alike.
Proven Similarity and Comprehensive Data Support
The approval of Yesintek™ is based on a comprehensive analytical, preclinical, and clinical data package. The data demonstrate that it is highly similar to the reference biologic, Stelara®, with no clinically meaningful differences in efficacy, safety, or immunogenicity. The biosimilar will be made available through the My Biocon Biologics™ Patient Support Program. The program provides tailored assistance to patients prescribed the therapy, ensuring smooth access and ongoing support.
Available formulations include:
*Yesintek™ (subcutaneous injection): 45 mg/0.5mL (prefilled syringe and vial) and 90 mg/mL (prefilled syringe)
*Yesintek™ I.V. (intravenous solution): 130 mg/26mL (5 mg/mL)
Strengthening Biocon Biologics’ Global Footprint
Shreehas Tambe, CEO and 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.”
Commitment to Affordable Biologics and Sustainable Healthcare
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 remains committed to advancing biosimilar adoption in Canada to improve patient outcomes and deliver meaningful savings to the healthcare system. By expanding access across both public and private markets, we aim to help build a sustainable biosimilars ecosystem that benefits all Canadians.”
Driving Broader Access to Biologic Therapies
With this approval, Biocon Biologics continues to reinforce its leadership in biosimilar innovation and accessibility. As per the press release, the launch of Yesintek™ in Canada adds to the company’s expanding global footprint. It underscores Biocon Biologics’ commitment to making advanced biologic treatments more affordable and widely available. This is a crucial step toward improving patients’ quality of life worldwide.
