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According to Biocon, the autoinjector offers patients in Canada a treatment option that is not available with the originator product. Biocon said the new delivery format will support more customised treatment approaches across different care settings and patient needs.
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Biocon's Canadian subsidiary has received approval from Health Canada for the Yesintek (ustekinumab) Autoinjector in 45 mg/0.5 mL and 90 mg/mL formulations on Wednesday, July 29.
The approval follows Health Canada's earlier clearance in October 2025 for Yesintek in prefilled syringe, vial and intravenous infusion formats, the company said in an exchange filing.
According to the company, the autoinjector offers patients in Canada a treatment option that is not available with the originator product. Biocon said the new delivery format will support more customised treatment approaches across different care settings and patient needs.
Yesintek is indicated for the treatment of moderate to severe plaque psoriasis in adults and children aged 6-17 years, active psoriatic arthritis in adults, and moderately to severely active Crohn's disease and ulcerative colitis in adults.
Biocon said the approval strengthens its immunology portfolio in Canada and supports its efforts to expand access to affordable medicines.
"This approval further strengthens Biocon's portfolio of immunology products in Canada and reaffirms the company's commitment to increasing patient access to affordable medicines around the world," a company spokesperson said.
The latest approval comes months after Health Canada cleared Yesintek in October 2025 across multiple presentations, including prefilled syringes, vials and an intravenous infusion formulation.
Earlier this month, the European Medicines Agency (EMA) approved a new drug product fill-finish line for Semglee (insulin glargine) at Biocon's insulin manufacturing facility in Malaysia. The company expects supplies to Europe from the new line to commence in the second quarter of FY27.
Shares of the company were trading off the day's lows at ₹431.70 as of 11.53 am on Wednesday, still down 0.17%. The stock has gained over 18% in the last six months and about 11% so far in this calendar year.
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