NeuClone Discloses Details of Denosumab' Biosimilar Candidate

Australian biopharmaceutical company NeuClone Pty Ltd has disclosed the fifth biosimilar candidate being developed in its pipeline of monoclonal antibody (mAb) products. The product is a biosimilar candidate for denosumab (branded as Prolia and XGEVA) currently in preclinical development.

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 ten biosimilars including denosumab.

As part of this collaboration, NeuClone is responsible for preclinical development and biosimilar product characterisation, whilst Serum Institute of India is responsible for process development and supply of commercial and clinical product. The announcement of the Prolia/XGEVA biosimilar follows on from the four previously disclosed biosimilars being developed that reference Herceptin (trastuzumab), Stelara (ustekinumab), Humira (adalimumab) and Synagis (palivizumab).

Denosumab is an IgG2 fully human mAb that is a RANK ligand (RANKL) inhibitor. Prolia/XGEVA was developed by Amgen and first approved in the United States in 2010. Prolia and XGEVA are approved for various indications including the treatment of osteoporosis, treatmentinduced bone loss, metastases to bone, giant cell tumour of bone and hypercalcemia of malignancy.