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 biological, osteoporosis treatment Amgen’s Prolia/Xgeva (denosumab), had estimated global sales of approximately US$4 billion in 2018. 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, where they will expire in 2025 [1].

The randomized, double-blind, two-group parallel, placebo-controlled, multicentre phase III clinical trial is being carried out in China. The study will compare the efficacy and safety of QL1206 versus placebo in the treatment of post-menopausal osteoporosis in women with high fracture risk.

Qilu intends to enrol 216 patients in one of two cohorts. Subjects will receive a single 60 mg injection of QL1206 or placebo every 6 months for 1 year, i.e. two subcutaneous injections. In addition, the subjects will take 500 mg of calcium and 1,000 IU of vitamin D daily.

The primary objective of the study is to evaluate the effect of QL1206 treatment compared with placebo. The secondary objective is to evaluate the clinical safety, immunogenicity and pharmacokinetic (PK) characteristics of QL1206. In addition, the study also has an exploratory purpose to evaluate the effect of anti-drug antibodies (ADA) on the characteristics of QL1206 PK and the relationship between QL1206 exposure and pharmacodynamic (PD) endpoints, efficacy and adverse events.

The trial is planned to be completed in July 2021.

Qilu has also already carried out a phase I trial with QL1206 which compared the PK, safety and PD of QL1206 and Xgeva in 168 healthy adults. This phase I trial was completed in May 2019.

Editor’s comment
It should be noted that copy biologicals approved in China 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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Reference
1. Derbyshire M. Patent expiry dates for biologicals: 2018 update. Generics and Biosimilars Initiative Journal (GaBI Journal). 2019;8(1):24-31. doi:10.5639/gabij.2019.0801.003

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