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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. • These applications join others from Celltrion, Fresenius Kabi, and Samsung Bioepis, increasing the potential availability of denosumab biosimilars pending FDA approval. • Ongoing litigations between Amgen and several companies, including Celltrion and Samsung Bioepis, highlight the complex legal landscape surrounding denosumab biosimilars.

The U.S. Food and Drug Administration (FDA) has accepted biologics license applications (aBLAs) from Organon and Teva Pharmaceuticals for their respective biosimilar candidates referencing Amgen's Prolia® and Xgeva® (denosumab). These developments signal increasing competition in the denosumab market, potentially offering more affordable treatment options for patients with osteoporosis and cancer-induced bone loss.
Organon's application pertains to HLX14, a proposed biosimilar for denosumab, which they licensed the commercialization rights for in the U.S. from Shanghai Henlius Biotech. Teva's application is for TVB-009P, another proposed biosimilar of Prolia®. The FDA and the European Medicines Agency (EMA) have accepted Teva’s application for review.

Expanding Biosimilar Landscape for Denosumab

These applications join a growing list of denosumab biosimilar candidates awaiting FDA approval. Celltrion (CT-P41), Fresenius Kabi (FKS518), and Samsung Bioepis (SB16) also have applications under review. In March 2024, Sandoz's Jubbonti®/Wyost® (denosumab-bddz) was FDA-approved as interchangeable with Prolia®/Xgeva®.
Denosumab is a monoclonal antibody that inhibits RANKL, a key mediator of osteoclast formation, function, and survival. By binding to RANKL, denosumab prevents it from activating its receptor, RANK, on the surface of osteoclasts and their precursors. This inhibition reduces bone resorption, increasing bone mineral density and reducing the risk of fractures. Prolia® is indicated for the treatment of osteoporosis in postmenopausal women and men at high risk of fracture, while Xgeva® is used to prevent skeletal-related events in patients with bone metastases from solid tumors and for the treatment of giant cell tumor of bone.

Ongoing Legal Battles

The path to market for these biosimilars is not without its challenges. Amgen, the maker of Prolia® and Xgeva®, has filed lawsuits against Celltrion, Samsung Bioepis, and Fresenius Kabi, alleging patent infringement. Amgen and Sandoz settled their lawsuit in April 2024, with a U.S. market entry date for Jubbonti®/Wyost® by May 31, 2025, or earlier under certain undisclosed circumstances.
The acceptance of these aBLAs represents a significant step toward potentially increasing patient access to more affordable denosumab options. However, the ultimate availability of these biosimilars will depend on the outcomes of the ongoing litigations and the FDA's review process.
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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.

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 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.
The BLA is supported by comparative quality analytical studies and Phase 1 and Phase 3 clinical trials demonstrating HLX14's pharmacokinetic similarity and efficacy.

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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Teva's Denosumab Biosimilar Candidate, TVB-009P, Accepted for Review by FDA and EMA

Teva's TVB-009P, a biosimilar candidate to Prolia (denosumab), has been accepted for review by the FDA and validated by the EMA for treating osteoporosis.
The applications include all indications approved for Prolia, addressing conditions with a high risk of fracture, particularly in postmenopausal women.

Reference News

[1]
FDA Accepts aBLAs for Prolia® / Xgeva® Biosimilars from Organon and Teva | Venable LLP
jdsupra.com · Nov 5, 2024

Organon announced FDA acceptance of its aBLA for HLX14, a biosimilar of Amgen’s Prolia®/Xgeva® (denosumab), licensed fro...

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