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Biosimilars of denosumab Posted 23/02/2018

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.

The originator product, Amgen’s Prolia/Xgeva (denosumab), was approved by the US Food and Drug Administration (FDA) on 1 June 2010. Prolia was approved by the European Medicines Agency (EMA) for the treatment of bone resorption and postmenopausal osteoporosis on 26 May 2010 and Xgeva was approved for the treatment of bone fractures and neoplasm metastasis on 13 July 2011 [1]. Prolia/Xgeva had combined worldwide net sales of US$3.2 billion in 2016, and is a target for biosimilars developers.

The patents on Prolia/Xgeva will expire in the US on 19 February 2025 and will expire in Europe on 25 June 2022, except for France, Italy, Spain and the UK, expiring in 2025 [1]. Some of the denosumab biosimilars and non-originator biologicals* approved or in development are presented in Table 1.

Table 1: Biosimilars and non-originator biologicals* of denosumab approved or in development

Company name, Country

Product name

Stage of development

AryoGen Pharmed, Iran*


Phase III trial in osteoporosis expected to be completed in December 2019

BioXpress Therapeutics, Switzerland


In pipeline [2]

Intas Pharmaceuticals, India*


Phase III trial in osteoporosis expected to be completed in August 2017

Neuclone, Australia


Preclinical [3]

Oncobiologics, USA


Preclinical [4]

*See editor’s comment.

Editor’s comment
It should be noted that ‘similar biologics’ approved in India and ‘biogenerics’ approved in Iran might not have been authorized following as strict a regulatory process as is required for approval of biosimilars in the European Union. The EMA (European Medicines Agency) regulatory requirements ensure the same high standards of quality, safety and efficacy for biosimilars as for originator biologicals, and also include a rigorous comparability exercise with the reference product

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1.  Derbyshire M. Patent expiry dates for biologicals: 2016 update. Generics and Biosimilars Initiative Journal (GaBI Journal). 2017;6(1):27-30. doi:10.5639/gabij.2017.0601.006
2.  BioXpress Therapeutics. Biosimilar pipeline [homepage on Internet]. [cited 2018 Feb 23]. Available from: www.bioxpress.com/#!pipeline/c6gz
3.   GaBI Online - Generics and Biosimilars Initiative. Denosumab biosimilar being developed in Australia [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Feb 23]. Available from: www.gabionline.net/Biosimilars/News/Denosumab-biosimilar-being-developed-in-Australia
4.  Oncobiologics. Product pipeline. [homepage on Internet]. [cited 2018 Feb 23]. Available from: www.oncobiologics.com/as_biosimilars-pipeline

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Source: Amgen, EMA, US FDA

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