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 product is a proposed biosimilar to Amgen’s Prolia/Xgeva (denosumab), which had combined worldwide net sales of US$3.2 billion in 2016. The patents on Prolia/Xgeva expired in both Europe and the US on 22 December 2017 [1].

NeuClone has been developing the denosumab biosimilar in parallel with several other biosimilar candidates and has partnered with Serum Institute of India for the low-cost manufacture of 10 biosimilars including denosumab. As part of this collaboration, NeuClone is responsible for preclinical development and biosimilar product characterization, whilst Serum Institute of India is responsible for process development and supply of commercial and clinical product.

The company has also disclosed that in its pipeline it is also developing four other biosimilars that reference Herceptin (trastuzumab), Stelara (ustekinumab), Humira (adalimumab) and Synagis (palivizumab).

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Reference
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

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