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Biocon Launches Denosumab Biosimilars Bosaya™ / Aukelso™ in the United States

by Leah Watson; Robert S. Schwartz, Ph.D.
April 9, 2026

On April 7, 2026, Biocon announced the U.S. commercial launch of Bosaya™ / Aukelso™ (denosumab-kyqq), biosimilars of Amgen’s Prolia® / Xgeva® (denosumab). Both products were approved by the U.S. Food and Drug Administration in September 2025 and were granted interchangeable designation. Bosaya™ is indicated as a biosimilar to Prolia®, and Aukelso™ as a biosimilar to Xgeva®.

Biocon previously resolved BPCIA litigation with Amgen concerning these products in Amgen Inc. et al. v. Biocon Biologics Ltd. et al., No. 1:25-cv-13358 (D.N.J.), which was consolidated in In re Denosumab Patent Litigation, No. 1:25-md-03138 (D.N.J.). The settlement provided for an injunction that expired on October 1, 2025.

Other denosumab biosimilars have already launched in the United States beginning in June 2025, including Sandoz’s Jubbonti® / Wyost® (denosumab-bbdz), Celltrion’s Stoboclo® / Osenvelt® (denosumab-bmwo), Fresenius Kabi’s Conexxence™ / Bomyntra™ (denosumab-bnht), and Hikma’s Enoby™ / Xtrenbo™ (denosumab-qbde) (previously reported Sandoz Launches Jubbonti® / Wyost® (denosumab-bbdz) as First Prolia® / Xgeva® Interchangeable Biosimilars; Fresenius Kabi and Celltrion Launch Prolia® / Xgeva® (denosumab) Biosimilars Conexxence™ / Bomyntra™ and Stoboclo® / Osenvelt®; Hikma Announces U.S. Launch of Prolia® / Xgeva® Biosimilars Enoby™ / Xtrenbo™ (denosumab-qbde)).

Amgen reported FY25 U.S. sales for Prolia® of $2.978 billion, and $1.355 billion for Xgeva®.

For more information about these and other biosimilars, please visit BiologicsHQ.

 

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The authors would like to thank April Breyer Menon for her contributions to this article.

    Methodology

    Information contained in the Venable BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website (www.fda.gov). Information relating to FDA licensed products, FDA-approved indications, and aBLA and 505(b)(2) applications is obtained from public sources including the U.S. FDA website (www.fda.gov). Information relating to litigations is given only for cases active from January 31, 2010 onward. Information relating to foreign biosimilar / biologics follow-on products approved in Australia, Canada, the E.U., Japan and South Korea is from public sources. Statistics graphics are compiled from information contained in the Venable BiologicsHQ database.

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