Eculizumab is a humanized monoclonal antibody that is a terminal complement inhibitor. It is used to treat people with paroxysmal nocturnal haemoglobinuria (PNH), for whom it improves quality of life but does not appear to affect the risk of death. It is also indicated for the treatment of patients with atypical haemolytic uremic syndrome (aHUS) – a disease that primarily affects kidney function – to inhibit complement-mediated thrombotic microangiopathy.

China’s National Medical Products Administration (NMPA) gave approval for Samsung Bioepis and partner, China-based AffaMed Therapeutics (AffaMed), to start the phase III trial of its eculizumab copy biological SB12 (also called AMT904 in China) on 10 January 2020. The approval of the clinical trial application (CTA) allows the start of the phase III clinical study at Chinese sites.

SB12 has been developed by Samsung Bioepis for the treatment of PNH and the company has responsibility for its global clinical trials conducted across 10 countries [1]. AffaMed is responsible for SB12 (AMT904)’s approval in China, based on the ongoing global phase III trial conducted by Samsung Bioepis. AffaMed received exclusive rights to commercialize the treatment in China and Singapore. To date, SB12 (AMT904) is the only candidate copy biological referencing Soliris (eculizumab) to be granted investigational new drug (IND) approval in China.

The trial is a multinational, multicentre, double-blind, randomized, active-controlled, study. Samsung Bioepis started the study in August 2019 and expects to enrol 50 patients with PNH globally. The study will compare the efficacy, safety, pharmacokinetics and immunogenicity of SB12 versus the originator drug, Soliris. The clinical study preparations in China are on track and the first Chinese patient visit is scheduled for the first quarter of 2020.

The CTA approval in China allows Samsung Bioepis to expand its global phase III clinical trial to include Asian markets. The decision by the NMPA also marks AffaMed’s second CTA approval in China. In December 2019, the companies also received CTA approval from the Chinese regulator to start a phase III trial of SB3 (trastuzumab).

Samsung Bioepis and AffaMed are also collaborating in China on copy biologicals referencing Lucentis (ranibizumab) and Eylea (aflibercept).

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. GaBI Online - Generics and Biosimilars Initiative. Samsung Bioepis starts phase III trial for eculizumab copy biological [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Feb 14]. Available from: www.gabionline.net/Biosimilars/News/Samsung-Bioepis-starts-phase-III-trial-for-eculizumab-copy-biological

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