Sandoz to start phase III trial for denosumab biosimilar

Biosimilars/News | Posted 26/07/2019 post-comment0 Post your comment

Sandoz, the generics division of Novartis, is planning to start a phase III trial for its candidate denosumab biosimilar GP2411 in patients with post-menopausal osteoporosis in collaboration with Germany-based biosimilars maker Hexal.

Bone cells V17C04

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 phase III trial is a multicentre, randomized, parallel arm, double-blind study with a total duration up to 82 weeks. Approximately 522 postmenopausal patients with osteoporosis will be randomized at the beginning of Treatment Period 1 (Baseline to Week 52) to receive two subcutaneous (60 mg/mL) doses every 6 months of either GP2411 or the EU-authorized originator Prolia (denosumab).

At the beginning of Treatment Period 2 (Week 52 to Week 78) patients in Treatment Period 1 Prolia group will be re-randomized 1:1 to either continue with a third dose of EU-authorized Prolia or will be transition to GP2411. All patients in the GP2411 group will continue the treatment with a third dose of GP2411.

The primary endpoints of the study are:
• per cent change from baseline (%CfB) in lumbar spine bone mineral density at Week 52
• area under the effect versus time curve (AUEC) after first dose, per cent change from baseline in serum Collagen C-telopeptide (CTX) at Week 52
• serum PK (pharmacokinetics) parameter AUCinf after first dose at Week 52
• serum PK parameter Cmax after first dose at Week 52

Secondary endpoints include occurrence of adverse events, serious adverse events and anti-drug antibodies (ADAs).

The trial is expected to be completed in July 2022.

Australian biologicals company NeuClone is also working on a denosumab biosimilar [1]. Phase III trials for denosumab products have also been started by Iran-based AryoGen Pharmed and by India-based Intas Pharmaceuticals.

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. GaBI Online - Generics and Biosimilars Initiative. Denosumab biosimilar being developed in Australia []. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Jul 26]. Available from: 

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