Samsung Bioepis starts phase III trial for bevacizumab biosimilar Posted 29/04/2016

South Korean electronics giant Samsung and biotechnology company Biogen Idec’s joint venture Samsung Bioepis has started a phase III clinical trial for a biosimilar version of Roche’s cancer blockbuster Avastin (bevacizumab).

Bevacizumab is a humanized monoclonal antibody. It inhibits angiogenesis (the formation of new blood vessels) by blocking the action of vascular endothelial growth factor A (VEGF-A). Bevacizumab can therefore slow the growth of new blood vessels in tumours and is used to treat various cancers, including colorectal, lung, breast, glioblastoma, kidney and ovarian.

The global clinical trial will be carried out in 678 patients, with 289 coming from the European Economic Area (EEA). The study is designed to compare the efficacy, safety, pharmacokinetics and immunogenicity between SB8 (proposed bevacizumab biosimilar) and Avastin in subjects with metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC).

The trial, which is currently ongoing, according to the EU Clinical Trials Register, is a multicentre, double-blind, randomized, active controlled, parallel-group study. The primary objective of the study is to demonstrate the equivalence of SB8 to Avastin, in terms of the best overall response rate (ORR) by 24 weeks of chemotherapy in subjects with metastatic or recurrent NSCLC. Secondary objectives for the trial include evaluation of the efficacy of SB8 compared to Avastin in terms of progression-free survival (PFS), overall survival (OS) and duration of response (DOR), as well as evaluation of the safety and tolerability, pharmacokinetics and immunogenicity of SB8 compared to Avastin.

The trial will be carried out in Belarus, Georgia, Germany, Hungary, Korea, Poland, Romania, Russia, Serbia, Spain, Taiwan and Ukraine.

The originator product, Roche’s Avastin had 2014 sales of US$7.4 billion making it a popular target for biosimilar developers. The patents on Avastin are set to expire in Europe in January 2022 and in the US in July 2019 [1].

In January 2016, Samsung Bioepis received European marketing approval for its etanercept biosimilar, Benepali (SB4) [2]. In April 2016, the company had its biosimilar infliximab Flixabi (SB2) recommended for approval by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) [3].

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Biosimilars of bevacizumab

References
1. Derbyshire M. Patent expiry dates for best-selling biologicals. Generics and Biosimilars Initiative Journal (GaBI Journal). 2015;4(4):178-9. doi:10.5639/gabij.2015.0404.040
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Apr 29]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
3. GaBI Online - Generics and Biosimilars Initiative. EMA recommends approval of infliximab biosimilar Flixabi [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Apr 29]. Available from: www.gabionline.net/Biosimilars/News/EMA-recommends-approval-of-infliximab-biosimilar-Flixabi

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Source: EU Clinical Trials Register

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