On March 5, 2024, the FDA approved Sandoz’s Jubbonti® and Wyost® (denosumab-bddz) as the first biosimilars of Amgen’s Prolia® and Xgeva® (denosumab). The launch date for these biosimilars has not been announced as Amgen and Sandoz continue their BPCIA litigation in the district of New Jersey.

Amgen filed its BPCIA Complaint (1:23-cv-02406 (D.N.J.)) on May 01, 2023, asserting that Sandoz’s aBLA for Jubbonti® / Wyost® infringed twenty-one of Amgen’s patents covering the reference products. Among these patents, two include formulation claims, three include composition of matter claims, and 20 include manufacturing claims.

On September 8, 2023, Amgen brought a motion for preliminary injunction and hearings were held in October through December 2023.  A decision on the preliminary injunction is pending. Sandoz was instructed to provide the Court with 30-days notice in advance of launching its biosimilar products, and to provide an update on the proposed target launch date by March 1, 2024. Sandoz’s communication with the Court regarding launch remains under seal. We continue to monitor this docket and will provide any updates once available.

As we have previously reported (see Celltrion Completes Application for FDA Approval of CT-P41, Biosimilar of Prolia® / Xgeva®), Celltrion also filed an aBLA for its denosumab biosimilar, CT-P41, that is currently pending.

Amgen reported 2023 U.S. sales of $2.7 billion for Prolia® and $1.5 billion for Xgeva®.

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



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


    Information contained in the Venable BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website ( 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 ( 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.


    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