News

News

Gedeon Richter and Hikma’s aBLA for Proposed Prolia® / Xgeva® (denosumab) Biosimilar RGB-14 Accepted by FDA

by Robert S. Schwartz, Ph.D.
December 18, 2024

On December 12, 2024, Gedeon Richter and Hikma announced the FDA acceptance of their aBLA for RGB-14 (denosumab), a proposed biosimilar of Amgen’s Prolia® / Xgeva® (denosumab).  This is the eighth publicly disclosed aBLA submission for a Prolia® / Xgeva® biosimilar, including Sandoz’s Jubbonti® / Wyost® (denosumab-bddz) (approved March 5, 2024 as interchangeable), and pending aBLAs from Celltrion: CT-P41 (accepted in November 2023), Fresenius Kabi: FKS518 (accepted in May 2024), Samsung Bioepis: SB16 (undisclosed filing date prior to August 2024), Teva: TVB-009P (accepted in October 2024), Organon / Shanghai Henlius Biotech: HLX14 (accepted in October 2024), and Accord / Intas: INTP23 (undisclosed filing date prior to November 2024).

There are numerous pending BPCIA litigations related to Prolia® / Xgeva® biosimilars, including those from Celltrion (Case No. 1:24-cv-06497 (D.N.J.)) (previously reported Amgen Files BPCIA Lawsuit Against Celltrion’s Proposed Prolia® / Xgeva® (Denosumab) Biosimilar CT-P41); Samsung Bioepis (Case No. 1:24-cv-08417 (D.N.J.)) (previously reported Amgen Files BPCIA Lawsuit Against Samsung Bioepis Prolia® / Xgeva® Proposed Biosimilar SB16); Fresenius Kabi (Case No. 1:24-cv-09555 (N.D. Ill.)) (previously reported Amgen Files Fourth BPCIA Lawsuit Against Proposed Prolia® / Xgeva® Biosimilar – Fresenius Kabi’s FKS518); and Accord / Intas (Case No. 5:24-cv-00642 (E.D.N.C.)) (previously reported BPCIA Lawsuit Against Accord’s Proposed Prolia® / Xgeva® Biosimilar Filed by Amgen).  Amgen filed a Motion to Transfer these cases to a Multidistrict Litigation (MDL #3138) in the District of New Jersey on November 15, 2024.  Briefing was completed on December 16, 2024, and a panel hearing has been set for January 30, 2025.

Sandoz settled its BPCIA litigation with Amgen in April 2024 (Case No. 1:23-cv-02406 (D.N.J.)), agreeing to a May 31, 2025 market entry date, or earlier under certain undisclosed circumstances (previously reported Amgen and Sandoz Settle Prolia® / Xgeva® Biosimilar Litigation).

Amgen reported 2023 U.S. sales for Prolia® of $2.73 billion, and $1.52 billion for Xgeva®.

For more information about these and other biosimilar aBLAs and patent disputes, 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