Biocon Gets Health Canada Nod For Two Denosumab Biosimilars; Shares Rise

Biocon has secured approval from Health Canada for two denosumab biosimilars, Bosaya and Vevzuo. These drugs can treat osteoporosis and bone issues linked to cancer. The company’s shares moved up after the announcement came out on Tuesday.

Biocon shares were trading 1.23% higher at ₹362.90 on the National Stock Exchange (NSE) as of 11:50 AM on 21 April, touching an intraday high of ₹364.70.

The stock has gained roughly 10% over the past year, with its 52-week high sitting at ₹424.95.

What Was Approved?

Health Canada granted a Notice of Compliance for both products. Bosaya is a biosimilar to Prolia, administered as a 60 mg/mL subcutaneous injection in a prefilled syringe.

The approvals were based on analytical, non-clinical and clinical data confirming both biosimilars are highly similar to their reference products with no clinically meaningful differences in quality, safety or efficacy.

What Did The Company Say?

Shreehas Tambe, CEO and Managing Director of Biocon, said the approvals show the company's scientific and regulatory capabilities and reinforce its commitment to patients with osteoporosis and cancer-related bone conditions. The company described the clearances as part of its strategy to expand access to affordable biologics across immunology and oncology in key global markets.

The Biocon approval comes against a broader tailwind for Indian pharma. The sector also received a policy boost in the Union Budget, where Finance Minister Nirmala Sitharaman announced Biopharma Shakti, a biosimilar and biologics strategy focused on health advancement through knowledge, technology and innovation, with an outlay of ₹10,000 crore over five years.

Also Read - Medical Inflation Pushes Health Insurance Costs Higher

Recent Financial Performance

Biocon's most recent quarterly results, for Q3 FY26, showed a recovery. Net profit jumped 475% to ₹144 crore from ₹25 crore a year earlier, driven by lower exceptional losses, higher other income and improved profitability across its biosimilars and generics divisions.

Operating revenue grew 9% to ₹4,173 crore in the quarter, with generics up 24% and biosimilars up 9%. Q4 FY26 results are expected in May 2026.

Sources:

CNBC TV18

Indian Express