News

News

FDA Approves Second Prolia® / Xgeva® (denosumab) Interchangeable Biosimilars: Samsung Bioepis’s Ospomyv™ / Xbryk™

by Robert S. Schwartz, Ph.D.
February 21, 2025

On February 13, 2025, the FDA approved Samsung Bioepis’s Ospomyv™ / Xbryk™ (denosumab-dssb) as the second interchangeable biosimilars of Amgen’s Prolia® / Xgeva® (denosumab).  On February 15, 2025, Samsung Bioepis announced the biosimilars had also been approved in the E.U. under the trade names Obodence™ / Xbryk™.

This approval follows Sandoz’s Jubbonti® / Wyost® (denosumab-bbdz), approved as interchangeable with Prolia® / Xgeva® in March 2024.  At least six other aBLAs for denosumab biosimilars remain pending at the FDA, including Celltrion’s CT-P41 (submitted in November 2023), Fresenius Kabi’s FKS518 (accepted in May 2024), Teva’s TVB-009P (accepted in October 2024), Organon / Shanghai Henlius Biotech’s HLX14 (accepted in October 2024), Accord / Intas’s INTP23 (undisclosed filing date prior to November 2024), and Gedeon Richter / Hikma’s RGB-14 (denosumab) (accepted in December 2024).

Samsung Bioepis is involved in a BPCIA litigation related to Ospomyv™ / Xbryk™, Case No. 1:24-cv-08417 (D.N.J.), which was consolidated into a multidistrict litigation (MDL1:25-md-03138 (D.N.J.)) on February 6, 2025, along with Amgen’s denosumab biosimilar cases against Fresenius Kabi (1:25-cv-01080 (D.N.J.)) (transferred from 1:24-cv-09555 (N.D. Ill.)) / MDL 1:25-md-03138 (D.N.J.)) and Accord (1:25-cv-01305 (D.N.J.)) (transferred from 5:24-cv-00642 (E.D.N.C.) / MDL 1:25-md-03138 (D.N.J.)).  Amgen v. Celltrion (1:24-cv-06497 (D.N.J.)) / MDL 1:25-md-03138 (D.N.J.)) was also included in the MDL, however it recently reached a consent injunction (previously reported Celltrion and Amgen Reach Settlement in Prolia® / Xgeva® Biosimilar Litigation) and, therefore, coordinated proceedings with the other cases may be more limited.

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 biosimilars, please visit BiologicsHQ.

 

_____________________________________________________

The author 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