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FDA Accepts BLA for Denosumab Biosimilar HLX14 Developed by Shanghai Henlius and Organon

• The FDA has accepted the Biologic License Application (BLA) for HLX14, a proposed biosimilar to denosumab (PROLIA/XGEVA), developed by Shanghai Henlius Biotech and Organon. • 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. • Organon holds exclusive commercialization rights for HLX14 in the U.S., EU, and Canada, granted by Shanghai Henlius Biotech in 2022, marking a significant step toward its market availability.

The U.S. Food and Drug Administration (FDA) has accepted the Biologic License Application (BLA) for HLX14, a proposed biosimilar to denosumab (marketed as PROLIA and XGEVA), as announced by Shanghai Henlius Biotech and Organon on October 30, 2024. This acceptance marks a crucial step toward potentially offering a more accessible treatment option for osteoporosis and other bone-related conditions. Shanghai Henlius Biotech granted Organon exclusive commercialization rights for HLX14 in the U.S., EU, and Canada in 2022.
The BLA submission is supported by comprehensive data derived from analytical assessments and two clinical trials designed to evaluate the biosimilarity of HLX14 to denosumab. These studies aimed to demonstrate comparable efficacy, safety, and immunogenicity profiles.

Clinical Trial Data Supporting HLX14

The clinical data supporting the HLX14 BLA includes a two-part Phase 1 trial conducted in healthy adult males in China. Part 1 was an open-label pilot study comparing the pharmacokinetics of HLX14 with EU-sourced PROLIA following subcutaneous injection. This initial study provided the foundation for Part 2, a double-blind, four-arm study that further examined HLX14's pharmacokinetic similarity to PROLIA sourced from the U.S., EU, and China. These trials were crucial in establishing the pharmacokinetic equivalence of HLX14 across different sourcing regions.
Further bolstering the BLA is data from a Phase 3 international study. This trial assessed the efficacy, safety, tolerability, and immunogenicity of HLX14 compared to EU-sourced PROLIA in postmenopausal women with osteoporosis at high risk of fracture. The study design adhered to rigorous standards to ensure a comprehensive evaluation of HLX14's clinical performance in a relevant patient population.

Implications for Osteoporosis Treatment

Osteoporosis is a significant public health concern, affecting millions worldwide and leading to increased fracture risk, particularly in postmenopausal women. Denosumab is a key treatment option for osteoporosis, reducing the risk of fractures by inhibiting osteoclast activity. The potential introduction of a biosimilar like HLX14 could increase access to this important therapy, potentially lowering healthcare costs and expanding treatment options for patients at risk of osteoporotic fractures.
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Reference News

[1]
FDA Accepts BLA for Shanghai Henlius Biotech's and Organon's HLX14, a Denosumab Biosimilar
jdsupra.com · Nov 9, 2024

FDA accepted Shanghai Henlius Biotech and Organon's BLA for HLX14, a denosumab biosimilar. Supported by phase 1 and 3 tr...

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