Recent biosimilar and biologic developments included Health Canada approval of denosumab biosimilars, FDA review actions, and new licensing and commercialisation agreements. Other updates covered court, trial and reimbursement agenda decisions.
Biocon has launched denosumab biosimilars Bosaya and Aukelso in the United States following FDA approval with interchangeable designation. The products target osteoporosis and bone metastases, entering a market where denosumab products generated approximately $5 billion in U.S. sales in 2024. The launch represents a strategic expansion of Biocon's biosimilar portfolio amid competitive market conditions.