News Related to Denosumab

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Senate Committee Advances Bill to Streamline Biosimilar Approvals

Aug 01, 2026

The Senate HELP Committee advanced a bill to streamline biosimilar approvals by relying on analytical tests, potentially cutting development costs and time. The FDA has issued guidance removing comparative efficacy studies and is working to speed post-exclusivity approvals. Combined with administration support and PBM reforms, these moves aim to increase biosimilar competition and reduce drug prices.

Biocon Launches Denosumab Biosimilars Bosaya and Aukelso in US Market

Apr 07, 2026

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.