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FDA Accepts Biosimilar Applications for Denosumab from Organon and Teva

• 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. • Ongoing litigations between Amgen and various biosimilar applicants highlight the complexities of bringing biosimilars to market.

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.
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HLX14's BLA is supported by analytical assessments, a Phase 1 trial in healthy adult males, and a Phase 3 trial in postmenopausal women with osteoporosis at high risk of fracture.

FDA Accepts Biologics License Application for Denosumab Biosimilar HLX14

The FDA has accepted Organon and Shanghai Henlius Biotech’s BLA for HLX14, a denosumab biosimilar, potentially expanding treatment options for osteoporosis and bone-related conditions.
HLX14's BLA submission includes data from comparative analytical studies and clinical trials, demonstrating its similarity to the reference drug, Prolia.

FDA Accepts Biosimilar Applications for Denosumab from Organon and Teva

The FDA has accepted Organon's aBLA for HLX14, a biosimilar candidate for Amgen's Prolia®/Xgeva® (denosumab), used in osteoporosis and cancer-induced bone loss.
Teva's application for its Prolia® biosimilar candidate, TVB-009P, has also been accepted for review by both the FDA and the EMA, expanding options for patients.

FDA Accepts Henlius' BLA for Denosumab Biosimilar HLX14 in Collaboration with Organon

The FDA has accepted Shanghai Henlius Biotech's BLA for HLX14, a biosimilar candidate for denosumab (PROLIA/XGEVA), used in osteoporosis treatment.
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FDA Accepts Biologic License Application for Denosumab Biosimilar HLX14

The FDA has accepted Organon's Biologic License Application (BLA) for HLX14, a biosimilar candidate for denosumab (Prolia/Xgeva).
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Reference News

[1]
FDA Accepts ABLAs For Prolia® / Xgeva® Biosimilars From Organon And Teva - Mondaq
mondaq.com · Nov 7, 2024

FDA accepts Organon's aBLA for HLX14, a Prolia®/Xgeva® biosimilar, and Teva's application for its Prolia® biosimilar TVB...

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