At the end of December 2019, Clover Biopharmaceuticals (Clover), a Chinese company focused on biological therapies, announced the start of a phase III trial of their etanercept copy biological (SCB-808), a proposed copy biological to originator biological Enbrel (etanercept).
Etanercept is a biological drug that treats autoimmune diseases by inhibiting tumour necrosis factor (TNF); a soluble inflammatory cytokine. Etanercept is indicated for the treatment of rheumatoid, juvenile rheumatoid and psoriatic arthritis, plaque psoriasis and ankylosing spondylitis [1].
The phase III, multicentre trial is designed to assess the efficacy, safety and pharmacokinetics (PK) of SCB-808 compared to the originator (Enbrel). The treatments are being administered subcutaneously to patients with ankylosing spondylitis.
Dr Feng Huang, principal investigator of the trial, said treatment of ankylosing spondylitis and other rheumatic diseases are an unmet need in China. ‘Currently, the lack of affordable, convenient and high-quality biological therapies presents a major hurdle to wide patient adoption and compliance’, said Dr Huang. ‘My team and I look forward to evaluating SCB-808 as a potential new and convenient therapeutic option for the treatment of patients with rheumatic diseases in China’, he added.
Dr Min Dong, Executive Vice President of Global Clinical Development at Clover, said ‘we hope that SCB-808 will meaningfully impact the lives of many patients in China who suffer from autoimmune diseases, and the initiation of this phase III trial brings us one step closer to this goal’.
The company says that all etanercept copy biologicals currently available in China were developed before the China Food and Drug Administration’s Technical Guideline for Development and Evaluation of Copy Biologicals were released [2], and therefore were not compared to Enbrel in clinical trials. These products are also only available in a powder form, which must be reconstituted before injection. By contrast, SCB-808 has a pre-filled syringe formulation, which is ready for injection and can be self-administered by patients.
As well as these points, Clover says the benefits of their drug include a robust manufacturing process. The company has a new state-of-the-art 35,000 m2 biomanufacturing facility, which is compliant with current good manufacturing practice (cGMP) and that has an initial bioreactor capacity of 2 x 2,000 L and that can also be expanded. According to Dr Peng Liang, Chairman and President of Clover, the company ‘has the vision and capacity to make a positive impact’ on the millions of patients with autoimmune conditions in China.
Editor’s comment
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 but they are not universally accepted by regulatory bodies outside of the European Union (EU). It should be noted that copy biologicals approved in China might not have been authorized if they had been subjected to the strict regulatory processes required for approval of biosimilars in the EU.
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References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of etanercept [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Mar 27]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-of-etanercept
2. Derbyshire M. Regulation of copy biologicals in China. Generics and Biosimilars Initiative Journal (GaBI Journal). 2018;7(2):75-6. doi:10.5639/gabij.2018.0702.015
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