Biocon Receives Health Canada Approval for Yesintek (Ustekinumab) Autoinjector Pen
核心洞察
Biocon's Canadian subsidiary received Health Canada approval for the Yesintek (ustekinumab) autoinjector in 45 mg/0.5 mL and 90 mg/mL formulations on July 29.
The autoinjector offers Canadian patients a delivery option not available with the originator product, supporting more customized treatment approaches across care settings.
Yesintek is indicated for moderate to severe plaque psoriasis (搜索), active psoriatic arthritis (搜索), and moderately to severely active Crohn's disease (搜索) and ulcerative colitis (搜索).
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, the company announced 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, according to an exchange filing.
According to Biocon, the autoinjector offers patients in Canada a treatment option that is not available with the originator product. The company said the new delivery format will support more customised treatment approaches across different care settings and patient needs.
Indications and Patient Population
Yesintek is indicated for the treatment of moderate to severe plaque psoriasis (搜索) in adults and children aged 6–17 years, active psoriatic arthritis (搜索) in adults, and moderately to severely active Crohn's disease (搜索) and ulcerative colitis (搜索) in adults.
Strategic Significance
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.
Related Developments
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.