On 20 April 2021, Korean pharmaceutical company, Huons Lab, announced the development of a denosumab biosimilar to treat osteoporosis. The company is working with PanGen Biotech and using their cell line culturing and purification technology.
The Huons Lab–PanGen Biotech agreement will take advantage of PanGen Biotech’s advanced technology to produce recombinant protein and develop process cell lines. Through this, Huons Lab hopes to rapidly develop the denosumab biosimilar to a stage where it can enter the Korean domestic and global markets.
Huons Lab has an existing agreement with Singapore-based Prestige BioPharma made in 2020 [1]. Here, Huons Lab has been granted exclusive Korean sales rights for HD204, an Avastin biosimilar, and PBP1502, a Humira biosimilar.
Amgen’s Prolia (denosumab) is the originator product with a patent ending in 2025. Denosumab is a humanized monoclonal antibody that is an inhibitor of the receptor activator of nuclear factor kappa-B ligand (RANKL). It works by preventing the development of osteoclasts 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 [2].
It has been estimated that the Prolia market grew to approximately US$5.13 billion worldwide in 2020. Cortellis, a healthcare research company, has estimated that the global Prolia market will expand 3.8 per cent annually until the patent expires. Huons and PanGen Biotech join a host of other pharmaceutical companies, in the development of denosumab biosimilars, these include Korea’s Samsung Bioepis [3], China’s Henlius [4], and Taiwan’s JHL Biotech [5].
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LATIN AMERICAN FORUM – Coming soon! To further enhance the objectives of GaBI in sharing information and knowledge that ensure policies supportive of safe biosimilars use, we are pleased to announce that we will be launching a new section on GaBI Online and GaBI Journal, the ‘Latin American Forum’ (in Spanish) featuring the latest news and updates on research and developments in generic and biosimilar medicines in Latin America. Register to receive the GaBI Latin American Forum newsletter. Inform colleagues and friends of this new initiative. LATIN AMERICAN FORUM – Próximamente! Para fomentar los objetivos de GaBI sobre la difusión de información y conocimiento sobre las políticas de apoyo que garantizan el uso seguro de medicamentos biosimilares, nos complace anunciar el lanzamiento de una nueva sección en GaBI Online y GaBI Journal, el ‘Latin American Forum’ (en español), que presentará las últimas noticias y actualizaciones en investigación y desarrollo sobre medicamentos genéricos y biosimilares en Latinoamérica. Regístrese para recibir el boletín informativo GaBI Latin American Forum. Informe a colegas y amigos sobre esta nueva iniciativa.
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References
1. GaBI Online - Generics and Biosimilars Initiative. Aurobindo and Huons refocus their biologicals biosimilars portfolios [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Apr 30]. Available from: www.gabionline.net/Pharma-News/Aurobindo-and-Huons-refocus-their-biologicals-biosimilars-portfolios
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of denosumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Apr 30]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-of-denosumab
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilar advances for Samsung Bioepis [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Apr 30]. Available from: www.gabionline.net/Biosimilars/General/Biosimilar-advances-for-Samsung-Bioepis
4. GaBI Online - Generics and Biosimilars Initiative. China accepts IND application for denosumab copy biological HLX14 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Apr 30]. Available from: www.gabionline.net/Biosimilars/News/China-accepts-IND-application-for-denosumab-copy-biological-HLX14
5. GaBI Online - Generics and Biosimilars Initiative. First subjects dosed in Australian phase I study of denosumab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Apr 30]. Available from: www.gabionline.net/Biosimilars/Research/First-subjects-dosed-in-Australian-phase-I-study-of-denosumab-biosimilar
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