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Biocon Biologics Secures U.S. Entry for Denosumab Biosimilars

Story Highlights
  • Biocon Biologics will launch Bosaya and Aukelso in the U.S. in October 2025.
  • The agreement with Amgen resolves patent litigation and strengthens Biocon’s oncology portfolio.
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Biocon Biologics Secures U.S. Entry for Denosumab Biosimilars

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Biocon Limited ( (IN:BIOCON) ) has shared an update.

Biocon Biologics, a subsidiary of Biocon Limited, has announced a settlement and license agreement with Amgen Inc., allowing the company to commercialize its denosumab biosimilars, Bosaya and Aukelso, in the U.S. market starting October 1, 2025. This development follows the U.S. FDA’s approval and provisional interchangeability designation for these products, which are biosimilars to Amgen’s Prolia and Xgeva. The agreement resolves pending patent litigation and marks Biocon Biologics’ entry into the bone health space, enhancing its oncology portfolio and reaffirming its position as a global leader in biosimilars.

More about Biocon Limited

Biocon Limited is a global biopharmaceutical company based in India, primarily focused on biosimilars, generic formulations, and novel biologics. The company operates in the healthcare sector, with a market focus on providing affordable and accessible medicines across various therapeutic areas, including oncology and bone health.

Average Trading Volume: 127,035

Technical Sentiment Signal: Buy

Current Market Cap: 453.9B INR

For a thorough assessment of BIOCON stock, go to TipRanks’ Stock Analysis page.

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