FDA Approves Eighth Denosumab Biosimilar as Amgen Settles Patent Dispute with Hikma and Gedeon Richter
核心洞察
The FDA approved Accord (搜索)'s Osvyrti/Jubereq (denosumab-desu) on November 20, 2025, marking the eighth biosimilar approval for Amgen's blockbuster osteoporosis (搜索) drugs Prolia and Xgeva.
Amgen reached a confidential settlement with Hikma (搜索) and Gedeon Richter on November 24, 2025, preventing commercial launch of their denosumab biosimilars until January 1, 2026.
Multiple denosumab biosimilar applications remain pending at FDA, including products from Teva (搜索), Amneal, and Alvotech/Dr. Reddy's, with ongoing patent litigation cases.
The FDA approved Accord (搜索)'s Osvyrti and Jubereq (denosumab-desu) on November 20, 2025, representing the eighth biosimilar approval for Amgen's blockbuster osteoporosis (搜索) and bone cancer (搜索) treatments Prolia and Xgeva (denosumab). This approval follows the September 26, 2025 approval of Gedeon Richter/Hikma (搜索)'s Enoby (搜索) and Xtrenbo (搜索) (denosumab-qbde), demonstrating the continued competitive pressure on Amgen's lucrative denosumab franchise.
Settlement Delays Biosimilar Competition
Despite receiving FDA approval in September, Hikma (搜索) and Gedeon Richter's denosumab biosimilars will not reach the market immediately. On November 24, 2025, the companies reached a confidential settlement agreement with Amgen in ongoing patent litigation, agreeing to an injunction that prevents commercial launch of Enoby (搜索) and Xtrenbo (搜索) until January 1, 2026.
The settlement resolves the Biologics Price Competition and Innovation Act (BPCIA) litigation filed by Amgen on June 25, 2025, which alleged that the biosimilars would infringe 32 patents. The U.S. District Court for the District of New Jersey entered a Consent Judgment and Injunction formalizing the agreement.
Expanding Biosimilar Pipeline
The denosumab biosimilar landscape continues to evolve with multiple applications pending at the FDA. Teva (搜索)'s TVB-009P was accepted in October 2024, while Amneal's MB09 and Alvotech/Dr. Reddy's AVT03 both received acceptance in March 2025. These pending applications suggest additional competition may emerge in the coming years.
Ongoing Patent Disputes
Amgen faces continued legal challenges as BPCIA litigation remains active for several other denosumab biosimilar developers. Ongoing cases include disputes with Shanghai Henlius Biotech (搜索) over Bildyos/Bilprevda (denosumab-nxxp), Alvotech/Dr. Reddy's AVT03, Amneal/mAbxience's MB09, and Alkem (搜索)'s ENZ215. These cases are proceeding in the U.S. District Court for the District of New Jersey.
The current settlement with Hikma (搜索) and Gedeon Richter follows Amgen's previous settlements of denosumab litigations with multiple companies, including Celltrion, Sandoz, Fresenius, Accord (搜索), Samsung Bioepis, and Biocon.
Market Impact
Amgen's denosumab products represent a significant revenue stream, with the company reporting fiscal year 2024 U.S. sales of $2.885 billion for Prolia and $1.507 billion for Xgeva, totaling $4.392 billion. The growing number of approved and pending biosimilars signals potential market share erosion as generic competition intensifies in this therapeutic area.