Biocon Biologics Gets Health Canada Nod for Biosimilars Yesintek and Yesintek IV
NEW DELHI: Biocon Ltd on Thursday announced that its subsidiary, Biocon Biologics Ltd, has received approval from Health Canada for its chronic autoimmune disease treatments — Yesintek and Yesintek IV.
In a regulatory filing, the company said the Notice of Compliance (NOC) from Health Canada covers Yesintek (ustekinumab injection) and Yesintek IV (ustekinumab for injection, solution for intravenous infusion). Both products are biosimilars to Janssen’s Stelara and Stelara IV, respectively.
The approval, granted on October 17, clears the way for the commercial launch of the two products in Canada by mid-October, Biocon said.
“Health Canada’s approval of Yesintek marks a significant milestone in our mission to expand global access to high-quality biosimilars,” said Shreehas Tambe, CEO & Managing Director, Biocon Biologics. “Building on our successful US launch, this strengthens our North American presence and offers Canadian patients a more affordable treatment option for chronic autoimmune conditions.”
Yesintek and Yesintek IV are 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 — conditions that affect thousands of Canadians.
The therapies will be made available through the “My Biocon Biologics” patient support programme, offering assistance to patients prescribed these medications.
Yesintek will be available as a subcutaneous injection — 45 mg/0.5 mL (prefilled syringe and vial) and 90 mg/mL (prefilled syringe) — while Yesintek IV will be supplied as an intravenous solution, 130 mg/26 mL (5 mg/mL), the company added.
