Biocon Biologics Expands North American Presence with Health Canada Approval for Ustekinumab Biosimilar
Biocon Biologics Ltd (BBL) received approval from Health Canada for Yesintek™ and Yesintek™ I.V., biosimilars to Stelara® (ustekinumab). The products will be commercially available in mid-October 2025 for treating various conditions including plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. This approval marks BBL's entry into the Canadian market, expanding its North American presence and immunology portfolio. The company plans to support patients through the My Biocon Biologics™ program and aims to improve biosimilar adoption in Canada's public and private markets.

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Biocon Biologics Ltd (BBL), a subsidiary of Biocon Ltd, has achieved a significant milestone in its global expansion strategy. The company recently received approval from Health Canada for Yesintek™ and Yesintek™ I.V., biosimilars to Stelara® (ustekinumab).
Key Highlights
- Approval Date: October 17, 2025
- Commercial Availability: Mid-October 2025
- Indications: Treatment of moderate to severe plaque psoriasis, active psoriatic arthritis, moderately to severely active Crohn's disease, and ulcerative colitis
Product Details
Product | Formulation | Strengths |
---|---|---|
Yesintek | Subcutaneous injection | 45 mg/0.5ml (prefilled syringe and vial), 90 mg/ml (prefilled syringe) |
Yesintek I.V. | Intravenous solution | 130 mg/26mL (5mg/mL) |
Market Impact
This approval marks Biocon Biologics' entry into the Canadian market, following its successful launch in the United States. The expansion strengthens the company's presence in North America and enhances its immunology portfolio.
Shreehas Tambe, CEO & Managing Director of Biocon Biologics, emphasized the significance of this approval, stating, "Health Canada's approval of Yesintek™ marks a significant milestone in our mission to expand global access to high-quality biosimilars."
Patient Support
Biocon Biologics plans to make Yesintek available through the My Biocon Biologics™ patient support program, which will provide assistance to individuals prescribed with the therapy.
Market Strategy
Ramy Ayad, Head of Canada at Biocon Biologics, highlighted the company's commitment to advancing biosimilar adoption in Canada. The strategy aims to improve patient outcomes and deliver meaningful savings to the healthcare ecosystem by expanding access in both public and private markets.
Broader Impact
This approval aligns with Biocon Biologics' mission to transform healthcare and improve lives globally. The company has already commercialized 10 biosimilars across 120+ countries, serving over 6 million patients. With a pipeline of 20 biosimilar assets, Biocon Biologics continues to focus on key therapeutic areas including diabetology, oncology, immunology, and ophthalmology.
As Biocon Biologics continues to expand its global footprint, this latest approval in Canada represents a significant step forward in the company's growth strategy and its commitment to providing affordable access to high-quality biosimilars worldwide.
Historical Stock Returns for Biocon
1 Day | 5 Days | 1 Month | 6 Months | 1 Year | 5 Years |
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-0.31% | +1.88% | +1.52% | +8.71% | +12.22% | -12.52% |