On October 23, 2023, Biocon Receives Approval from Health Canada for two important biosimilar medicines, Yesintek and Yesintek IV. This major milestone strengthens Biocon Ltd’s global presence through its subsidiary, Biocon Biologics Ltd. The approval lets the company sell these drugs in Canada, giving patients with chronic autoimmune diseases more affordable treatment options.
Health Canada issued the Notice of Compliance (NOC) on October 17 after confirming that both medicines met Canadian safety and quality standards. Yesintek is an ustekinumab injection, and Yesintek IV is an intravenous infusion. Both medicines are biosimilars to Stelara and Stelara IV, which doctors use to treat immune-related diseases. Since biosimilars work the same way as their original drugs but cost less, they make advanced treatments more accessible to patients.
Shreehas Tambe, CEO and Managing Director of Biocon Biologics, said this approval marks “a significant step in expanding access to high-quality biosimilars.” He added that Biocon remains committed to improving treatment access for patients worldwide, especially in Canada.
Yesintek and Yesintek IV treat several serious autoimmune conditions, including:
- Moderate to severe plaque psoriasis in adults and children aged 6–17 years.
- Active psoriatic arthritis in adults.
- Moderately to severely active Crohn’s disease in adults.
- Ulcerative colitis in adults.
These conditions often cause long-term pain and emotional distress. Affordable biosimilars like Yesintek can ease the burden for both patients and healthcare systems.
To assist Canadian patients, Biocon launched a support program called My Biocon Biologics. It helps patients prescribed Yesintek or Yesintek IV with insurance coverage, financial aid, and treatment guidance. This initiative ensures that cost or accessibility issues do not prevent anyone from receiving care.
Yesintek is available in two forms:
- Injection: 45 mg/0.5 ml and 90 mg/ml in prefilled syringes and vials.
- Intravenous solution: 130 mg/26 ml (5 mg/ml).
Biocon Ltd, based in Bengaluru, India, has become a global leader in biosimilars. Its subsidiary, Biocon Biologics, plays a key role in making advanced medicines affordable in India, the U.S., and Europe. By 2023, India ranked among the top 10 countries worldwide in biosimilar production, showing its strength in biotechnology.
In addition, North India, especially Chandigarh, is rapidly emerging as a healthcare and biotech hub. The growing number of startups and investments in biosciences shows India’s progress in cost-effective medical innovation. Biocon’s recent success highlights how Indian companies can compete globally and drive healthcare improvements.
With this achievement, Biocon strengthens its mission to make modern therapies both accessible and affordable. This success benefits Canadian patients while also showcasing India’s expanding role in the global pharmaceutical industry. However, the success of Biocon receives approval from health Canada reflects a future where innovation and affordability work together to improve lives across the world.
