Biocon Biologics, a fully-integrated global biosimilars company, said it received approval for the Yesintek and Yesintek IV (ustekinumab injection), a biosimilar to Stelara IV on October 17.
The injections are indicated for the treatment of moderate to severe plaque psoriasis in adult patients and in paediatric patients (Age 6-17), active psoriatic arthritis in adults, moderately to severely active Crohn's disease and ulcerative colitis in adults —a range of debilitating autoimmune conditions that affect thousands of Canadians, the company said.
Yesintek will be available via the My Biocon Biologics patient support programme, which provides assistance to individuals prescribed with therapy. It is available as a subcutaneous injection, 45 mg/0.5 ml (pre-filled syringe and vial) and 90 mg/ml (pre-filled syringe) and Yesintek IV is an intravaous solution, 130 mg/26ml (5mg/ml).
"Building on our successful US launch, this approval strengthens our presence in North America and enhances our immunology portfolio with a more affordable treatment option for Canadian patients living with chronic autoimmune conditions," Shreehas Tambe, CEO and managing director of Biocon Biologics, said.
Shares of Biocon are trading 0.8% higher on Thursday at ₹369. The stock is up nearly 3% in the last one month. On a year-to-date basis, the stock is flat.
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