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2025-09-17|

Biocon Biologics Gains FDA Approval for Two Denosumab Biosimilars Bosaya and Aukelso

by Mark Chiang
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Biocon Biologics Ltd. has received approval from the U.S. Food and Drug Administration (FDA) for two biosimilar products, Bosaya™ and Aukelso™, both of which are denosumab biosimilars. The announcement was made on September 17, 2025, by the Bengaluru-based company, a subsidiary of Biocon Ltd., which specializes in developing and manufacturing biosimilars for global markets.

The FDA’s approval marks a significant regulatory milestone for Biocon Biologics as it expands its portfolio in the U.S. market. Denosumab is commonly used to treat conditions such as osteoporosis and bone-related complications associated with cancer. The approval of Bosaya™ and Aukelso™ positions these products as alternatives to existing branded treatments, offering healthcare providers additional options for managing these conditions.

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Source: GO-AI-ne1

Date: September 17, 2025

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