Unveiling key clinical findings for denosumab biosimilar candidates

Biosimilares/Investigación | Posted 07/05/2024 post-comment0 Post your comment

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.

03 AA010722

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 multicentre, 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.

Related articles
First denosumab biosimilars approved in Canada and the US

Spinoff updates: Merck’s Organon and Novartis’ Sandoz 

Denosumab copy biological clinical trial application accepted in China

The new section of the ‘Latin American Forum’ on GaBI has been launched. The objective of this new section is to provide you with all the latest news and updates on developments of generic and biosimilar medicines in Latin America in Spanish.

View the latest headline article: Se lanza la Estrategia de Certidumbre Regulatoria para biosimilares en México

Browse the news in the Latin American Forum!

Register to receive the GaBI Latin American Forum newsletter. Inform colleagues and friends of this new initiative.

Se ha lanzado la nueva sección del ‘Foro Latinoamericano’ sobre GaBI. El objetivo de esta nueva sección es brindarle las últimas noticias y actualizaciones sobre desarrollos de medicamentos genéricos y biosimilares en América Latina en español.

Ver el último artículo de cabecera: Se lanza la Estrategia de Certidumbre Regulatoria para biosimilares en México

!Explore las noticias en el Foro Latinoamericano!

Regístrese para recibir el boletín informativo GaBI Foro Latinoamericano. Informe a colegas y amigos sobre esta nueva iniciativa. 


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

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2024 Pro Pharma Communications International. All Rights Reserved.

comment icon Comments (0)
Post your comment
Most viewed articles
Sobre GaBI
INICIO/Sobre GaBI Posted 06/08/2009
EU guidelines for biosimilars
EMA logo 1 V13C15
INICIO/Directrices Posted 08/10/2010