FDA Accepts Henlius' BLA for Denosumab Biosimilar HLX14 in Collaboration with Organon
Key Insights
The FDA has accepted Shanghai Henlius Biotech (search)'s BLA for HLX14, a biosimilar candidate for denosumab (PROLIA/XGEVA), used in osteoporosis (search) 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.
Organon holds exclusive commercialization rights for HLX14 in the US, EU, and Canada (excluding China) under a licensing and supply agreement with Henlius.
The U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for HLX14, a biosimilar candidate of denosumab, developed by Shanghai Henlius Biotech (search) in collaboration with Organon. This acceptance marks a significant step toward providing a more accessible treatment option for conditions like osteoporosis (search). Denosumab, marketed as PROLIA and XGEVA, is currently approved for treating osteoporosis in postmenopausal women at high risk of fractures, among other indications.
Clinical Trial Data Supporting HLX14
The BLA submission is backed by comprehensive data from a series of head-to-head studies. These include comparative quality analytical studies and two clinical trials designed to evaluate the biosimilarity of HLX14 to the reference product. The clinical program included:
- Phase 1 Study: A two-part study in healthy adult male participants in China. Part 1 focused on comparing the pharmacokinetic (PK) parameters of HLX14 and EU-sourced PROLIA after subcutaneous injection. Part 2 was a double-blind, randomized study comparing HLX14 with PROLIA sourced from the US, EU, and China.
- Phase 3 Trial: A randomized, double-blind, international multicenter trial that assessed the efficacy, safety, tolerability, and immunogenicity of HLX14 compared to EU-sourced reference PROLIA in postmenopausal women with osteoporosis at high risk of fractures.
Commercialization Agreement
In 2022, Henlius and Organon entered into a licensing and supply agreement, granting Organon exclusive commercialization rights for HLX14 in the US, the European Union (EU), and Canada, excluding China. This strategic partnership aims to leverage Organon's global reach to bring HLX14 to a wider patient population.
About Denosumab and Osteoporosis
Denosumab is a monoclonal antibody that inhibits RANKL (search), a key mediator of osteoclast formation, function, and survival. By blocking RANKL, denosumab reduces bone resorption, thereby increasing bone mineral density and reducing the risk of fractures. Osteoporosis (search) is a common condition, particularly among postmenopausal women, characterized by decreased bone strength, leading to an increased risk of fractures. The availability of a biosimilar like HLX14 could potentially lower treatment costs and improve access to this important therapy.
Henlius' Broader Portfolio
Henlius has a diversified product pipeline, including biosimilars and innovative therapies. Their portfolio includes HANLIKANG (search) (rituximab), HANQUYOU (search) (trastuzumab), HANDAYUAN (search) (adalimumab), HANBEITAI (search) (bevacizumab), HANNAIJIA (search) (neratinib), and HANSIZHUANG (search) (serplulimab).