Biocon shares down despite getting Health Canada nod for biosimilars Yesintek, Yesintek IV

The notice of compliance (NOC) granted by Health Canada is for Yesintek (ustekinumab injection) and Yesintek IV (ustekinumab for injection, solution for intravenous infusion), Biocon Ltd said in a regulatory filing.

Yesintek and Yesintek IV are biosimilars to Stelara (ustekinumab injection) and Stelara IV (ustekinumab for injection, solution for intravenous infusion), respectively.

The approval was granted on October 17, paving the way for Canadian commercial availability in mid-October, the company said.

Biocon share price

The stock is trading 0.4% lower at ₹364.65 per unit on the National Stock Exchange at 11:02 am.

"Health Canada's approval of Yesintek marks a significant milestone in our mission to expand global access to high-quality biosimilars," Biocon Biologics CEO & Managing Director Shreehas Tambe said.

He further said, "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."

Yesintek and Yesintek IV are indicated for the treatment of moderate to severe plaque psoriasis in adult patients and in pediatric patients (6-17 years of age), 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 through the "My Biocon Biologics" patient support programme, which provides assistance to individuals prescribed with the therapy, it added.

Biocon said Yesintek is available as a subcutaneous injection, 45 mg/0.5ml (prefilled syringe and vial) and 90 mg/ml (prefilled syringe) and Yesintek I.V. as an intravenous solution, 130 mg/26mL (5mg/mL).