India Pharma Outlook Team | Thursday, 30 July 2026
Biocon has secured a major regulatory milestone with Health Canada's approval for its Autoinjector Pen version of Yesintek.
The approval strengthens the company's biosimilar portfolio in North America. It also expands treatment options for patients with chronic autoimmune diseases.
The move supports Biocon's strategy to increase global access to affordable biologic medicines. The approval follows a detailed review of the product's safety, efficacy, and quality.
Health Canada Approval Expands Yesintek Portfolio
Biocon Biologics announced that Health Canada has approved the Yesintek single-use autoinjector. The product contains ustekinumab, a biosimilar to Stelara. The approval adds another delivery option for patients requiring long-term treatment.
The newly approved autoinjector joins the existing Yesintek presentations already available in Canada. These include prefilled syringes, vials, and intravenous formulations. Patients and healthcare providers can now choose another administration option.
Health Canada's decision followed the review of clinical and scientific evidence. The regulator concluded that Yesintek is highly similar to Stelara. It found no clinically meaningful differences in safety, efficacy, or immunogenicity.
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Treatment Targets Multiple Autoimmune Diseases
Yesintek is approved for several chronic autoimmune conditions. These include moderate to severe plaque psoriasis in adults. It is also approved for children aged six to 17 years.
The treatment is indicated for adults with active psoriatic arthritis. It also covers moderately to severely active Crohn's disease. Another approved indication is ulcerative colitis in adults. These diseases affect thousands of patients across Canada.
According to the company, expanding delivery options can improve patient convenience. It may also support better treatment adherence during long-term therapy.
Key Highlights
Biocon Strengthens North America Presence
The latest approval adds another milestone for Biocon Biologics in global biosimilars. The company has continued expanding its immunology portfolio across major markets.
Shreehas Tambe, CEO and Managing Director of Biocon Biologics, says the approval supports the company's mission to improve access to high-quality biosimilars.
The company also confirmed that eligible patients can receive support through the My Biocon Biologics patient support program. The initiative helps patients prescribed the therapy throughout their treatment journey.
With the latest approval, Biocon continues building its presence in regulated global markets. The move also reflects growing acceptance of biosimilars as cost-effective alternatives to reference biologic medicines.
