FDA Accepts Biosimilar Applications for Denosumab from Organon and Teva

Key Insights

• Organon's aBLA for HLX14, a proposed biosimilar of Amgen's Prolia®/Xgeva® (denosumab), has been accepted by the FDA, marking a step toward alternative treatment options.
• Teva also announced FDA and EMA acceptance of applications for its Prolia® biosimilar candidate TVB-009P, joining the race for denosumab biosimilars.
• These applications add to the growing list of denosumab biosimilars awaiting FDA approval, potentially increasing market competition and patient access.

The FDA has accepted biologics license applications (aBLAs) from Organon and Teva Pharmaceuticals for their respective proposed biosimilars of Amgen's Prolia® and Xgeva® (denosumab). These developments signal increasing competition in the denosumab market, potentially offering more affordable treatment options for patients.

Organon announced the FDA acceptance of its aBLA for HLX14, a proposed biosimilar of denosumab, on October 30, 2024. Organon licensed the commercialization rights for HLX14 in the U.S. from Shanghai Henlius Biotech. Earlier in October, Teva announced that the FDA and EMA accepted applications for its proposed Prolia® biosimilar TVB-009P.

Expanding Biosimilar Landscape

Organon and Teva's applications join those from Celltrion, Fresenius Kabi, and Samsung Bioepis for denosumab biosimilars CT-P41, FKS518, and SB16, respectively, which are awaiting FDA approval. In March 2024, Sandoz's Jubbonti® / Wyost® (denosumab-bddz) was FDA-approved as interchangeable with Prolia® / Xgeva®.

Ongoing Legal Challenges

Litigation is ongoing between Amgen and Celltrion (Case No. 1:24-cv-06497 (D.N.J.)), Samsung Bioepis (Case No. 1:24-cv-08417 (D.N.J.)), and Fresenius Kabi (Case No. 1:24-cv-0955 (N.D. Ill.)). Amgen and Sandoz settled their lawsuit (Case No. 1:23-cv-02406) in April 2024, with a U.S. market entry date for Jubbonti® / Wyost® by May 31, 2025, or earlier under certain undisclosed circumstances.

Denosumab Market and Clinical Use

Denosumab is a monoclonal antibody that inhibits RANKL, a key mediator of osteoclast formation, function, and survival. Prolia® is approved for the treatment of osteoporosis in postmenopausal women and men at increased risk of fracture, while Xgeva® is used to prevent skeletal-related events in patients with bone metastases from solid tumors. The entry of biosimilars into the market could significantly impact treatment costs and accessibility for these patient populations.