In April 2024, Henlius Biotech and Organon announced that the phase III comparative clinical trial for their investigational denosumab biosimilar (HLX14) met the primary endpoints. This follows the news released earlier in the year, that Alvotech and Polpharma achieved positive topline results from their pharmacokinetic (PK) studies for their denosumab biosimilar candidate (AVT03). The originator product is Amgen’s Prolia/Xgeva.
Denosumab is a humanized monoclonal antibody that is an inhibitor of the receptor activator of nuclear factor kappa-B ligand (RANKL), which works by preventing the development of osteoclasts which are cells that break down bone. It is used for the treatment of osteoporosis, treatment-induced bone loss, metastases to bone and giant cell tumour of bone [1].
The originator product, Amgen’s Prolia/Xgeva (denosumab), is marketed as Prolia for the treatment of osteoporosis. A different dose of the antibody is marketed as Xgeva for preventing bone problems in multiple myeloma patients and those whose solid tumours have metastasized to the bones.
Henlius-Organon phase III study
Henlius and Organon entered into a strategic partnership in 2022 [2]. Henlius has exclusive commercialization rights to two biosimilar candidates, including HLX14. The agreement covers markets such as Canada, the European Union, and the US. An exception to the agreement is China.
The study was a randomized, double-blind, international multicenter, parallel-controlled phase III clinical study. It aimed to compare the efficacy, safety, tolerability, and immunogenicity of HLX14 with EU-sourced reference denosumab (Prolia) in postmenopausal women with osteoporosis at high risk for fracture. There were two primary endpoints that were met in the study, these related to the percentage change in bone mineral density (BMD) and the pharmacodynamics of the biosimilar as compared to the reference product.
Alvotech PK study on denosumab
The Alvotech PK study (AVT03-GL-P01), assessed the pharmacokinetics, safety, and tolerability of AVT03 compared to Prolia in healthy adult subjects, and met its primary endpoints. A confirmatory efficacy study for AVT03 in patients is now underway, as well as a PK study comparing AVT03 to Xgeva in healthy adult subjects.
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References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of denozumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 May 7]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-of-denosumab
2. GaBI Online - Generics and Biosimilars Initiative. Organon–Henlius partnership: biosimilars for women’s health [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 May 7]. Available from: www.gabionline.net/pharma-news/organon-henlius-partnership-biosimilars-for-women-s-health
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