Biocon Ltd announced that its subsidiary in Canada has received Notice of Compliance (NOC) approval from Health Canada for the Yesintek (ustekinumab) autoinjector. According to the company's regulatory filing, the approval covers Yesintek Autoinjector 45 mg/0.05 mL and 90 mg/mL for the treatment of moderate to severe plaque psoriasis. This marks a significant milestone for the company's Canadian operations in the pharmaceutical sector, with the approval received on July 29, 2026. The autoinjector format provides a delivery method not currently offered by the originator product in Canada, allowing for customised treatment approaches across care settings and patient needs.
As reported by Biocon, Health Canada had previously granted NOC approval for Yesintek in October 2025. The earlier approvals included Yesintek solution for subcutaneous injection 45 mg/0.5ml (prefilled syringe and vial) and Yesintek I.V. solution for intravenous infusion 130 mg/26 mL (5mg/mL). The autoinjector approval represents the latest addition to the company's comprehensive product portfolio in the Canadian market, following Health Canada's earlier clearance across multiple presentations. The new autoinjector format complements the company's existing Yesintek offerings and enhances patient convenience by enabling self-administration.
According to Biocon, Yesintek is indicated for moderate to severe plaque psoriasis in adult patients and pediatric patients (6-17 years of age). The medication is also approved for active psoriatic arthritis in adults, moderately to severely active Crohn's disease and ulcerative colitis in adults. The company emphasized that this treatment addresses a range of debilitating autoimmune conditions affecting thousands of Canadians, expanding access to affordable medicines in the market. The self-administered autoinjector format specifically targets the autoinjector pen formulation of ustekinumab, a biologic therapy used to manage autoimmune conditions, potentially influencing prescribing patterns and patient preference.
As reported by Biocon, the availability of the Yesintek autoinjector provides patients with treatment options that the originator product does not offer in Canada. The company stated that the new delivery format will allow customised treatment approaches across care settings and patient needs. A company spokesperson noted that this approval further strengthens Biocon's competitive position in the Canadian biosimilar market and reaffirms the company's global mission to increase access to affordable medicines. With a growing presence in North America, Biocon continues to leverage its biosimilar expertise to compete with originator biologics, offering cost-effective solutions without compromising efficacy or safety. The company has been steadily building a portfolio of immunology products in Canada, leveraging regulatory approvals to compete with originator biologics.
According to Angel One, Biocon share price was trading at ₹431.50 per share as of July 29, 2026, at 11:20 AM, reflecting a decline of 0.22% from the previous trading session. The stock has gained over 18% in the last six months and about 11% so far in this calendar year. The latest approval comes months after Health Canada cleared Yesintek in October 2025 across multiple presentations, with the company's immunology portfolio in Canada being strengthened through this development. The expansion into autoinjector technology enhances patient convenience and adherence by enabling self-administration, potentially influencing prescribing patterns and patient preference in the Canadian autoimmune treatment sector.
