Denosumab-based therapies are widely used to increase bone mass, treat osteoporosis, and manage bone complications arising from cancers such as breast, prostate and lung cancer.
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The company said the approval is supported by analytical, non-clinical and clinical data demonstrating that the products are highly similar to their reference drugs, with no clinically meaningful differences in safety, efficacy or quality.Calling the Health Canada approval an “important milestone for Biocon,” Chief Executive Officer Shreehas Tambe said, “This approval reflects our strong scientific and regulatory capabilities and reinforces our commitment to patients living with osteoporosis and cancer-related bone conditions, while further strengthening our portfolio of affordable biologic therapies across immunology and oncology.”
Biocon added that the approval could benefit over two million adults with osteoporosis, as well as patients with bone metastases, expanding access to affordable biologic therapies in global markets.
Shares of the company gained following the announcement and were trading 1.49% up at ₹364.40 as of 10.34 am. The stock has gained about 10% over the last year.
Last week, Hemen Kapadia, Technical Associate at DRChoksey Finserv, recommended buying Biocon with a stop loss of ₹340 and a target of ₹385.
