News

News

Amgen and Biocon Reach Settlement in Prolia® / Xgeva® Biosimilar Litigation

by Leah Watson; Robert S. Schwartz, Ph.D.
September 30, 2025

On September 30, 2025, Amgen and Biocon Biologics reached a settlement in Case No. 1:25-cv-13358 (D.N.J.) / MDL 1:25-md-03138 (D.N.J.). The litigation related to Biocon’s Prolia® / Xgeva® (denosumab) provisionally interchangeable biosimilars Bosaya™ / Aukelso™ (denosumab-kyqq), which were approved by the FDA on September 16, 2025. The settlement allows Biocon to launch Bosaya™ / Aukelso™ from October 1, 2025. Additional terms of the settlement agreement have not been publicly disclosed.

This is the sixth settlement related to Prolia® / Xgeva® biosimilars. Previous settlements include  Amgen v. Sandoz, Case No. 1:23-cv-02406 (D.N.J.) in April 2024 related to interchangeable biosimilars Jubbonti® / Wyost® (denosumab-bbdz) (previously reported Amgen and Sandoz Settle Prolia® / Xgeva® Biosimilar Litigation); Amgen v. Celltrion, Case No. 1:24-cv-06497 (D.N.J.) in January 2025 related to Stoboclo® / Osenvelt® (denosumab-bmwo) (previously reported Celltrion and Amgen Reach Settlement in Prolia® / Xgeva® Biosimilar Litigation); Amgen v. Fresenius Kabi, Case No. 1:25-cv-01080 (D.N.J.) / MDL 1:25-md-03138 (D.N.J.) in March 2025 related to Conexxence™ / Bomyntra™ (denosumab-bnht) (previously reported Prolia® / Xgeva® (denosumab) Biosimilar Updates: Celltrion Biosimilar Approval, Amneal aBLA Filing, and Fresenius Kabi Litigation Settlement); Amgen v. Accord, Case No. 1:25-cv-01305 (D.N.J.) / MDL 1:25-md-03138 (D.N.J.) in July 2025 related to INTP23 (previously reported Amgen and Accord Settle Prolia® / Xgeva® BPCIA Litigation over INTP23); and Amgen v. Samsung Bioepis, Case No. 1:24-cv-08417 (D.N.J.) / 1:25-md-3138 (D.N.J.) in September 2025 related to Ospomyv™ / Xbryk™ (denosumab-dssb) (previously reported Amgen and Samsung Bioepis Reach Settlement in Prolia® / Xgeva® Biosimilar Litigation).

Sandoz’s biosimilars were launched in June 2025, and Celltrion and Fresenius Kabi’s biosimilars launched in July 2025 (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®). Under the settlement agreement with Accord, INTP23 will be able to launch once it is FDA approved.

Two lawsuits for Prolia® / Xgeva® biosimilars remain pending: Gedeon Richter / Hikma’s Enoby™ / Xtrenbo™ (denosumab-qbde) (Case No. 1:25-cv-12152 (D.N.J.)) and Shanghai Henlius Biotech / Organon’s Bildyos® / Bilprevda® (denosumab-nxxp) (Case No. 1:25-cv-12160 (D.N.J.)).

Amgen reported FY24 U.S. sales for Prolia® of $2.885 billion, and $1.507 billion for Xgeva®.

For more information about these and other biosimilar patent disputes, please visit BiologicsHQ.

 

_____________________________________________________

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.

    Disclaimer

    The individuals who maintain this site work for Venable LLP. The information, comments and links posted on this site do not constitute legal advice. No attorney-client relationship has been or will be formed by any communication(s) to, from or with the site and/or the author. For legal advice, contact an attorney at Venable LLP or an attorney actively practicing in your jurisdiction. Do not send any confidential or privileged information to the author; neither Venable LLP nor the author will assume any liability or responsibility for it. If you send any information, documents or materials to the site, you give permission for the author to include them on or in the site. No information, documents or materials you send to the site will be considered confidential or privileged by Venable LLP or its lawyers. Also, no such information, documents or materials will be returned to you. All decisions relating to the content belong to the author.

    Subscribe for Future Updates

      captcha