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