EMA accepts application for trastuzumab biosimilar

Biosimilars/News | Posted 07/10/2016 post-comment0 Post your comment

Samsung Bioepis, which is a joint venture between South Korean electronics giant Samsung and biotechnology company Biogen, announced on 3 October 2016 that its regulatory submission for its proposed trastuzumab biosimilar (SB3) had been accepted for review by the European Medicines Agency (EMA). The company says the marketing application was submitted in August 2016.

Application V15a16

Trastuzumab is a monoclonal antibody that interferes with the human epidermal growth factor receptor 2 (HER2)/neu receptor. In some cancers, notably certain types of breast cancer, HER2 is over-expressed, and causes cancer cells to reproduce uncontrollably. Trastuzumab is therefore used to treat certain breast cancers.

The product is a proposed biosimilar to Roche’s Herceptin (trastuzumab), which had worldwide sales of CHF 6.5 billion (US$6.6 billion) in 2015, making it a lucrative target for biosimilars’ manufacturers. The patents on Herceptin expired in Europe in July 2014 and will expire in the US in June 2019 [1].

SB3 is the fifth biosimilar candidate Samsung Bioepis has submitted to EMA, following SB4 (etanercept), SB2 (infliximab), SB9 (insulin glargine) and SB5 (adalimumab). Benepali (SB4) and Flixabi (SB2) received a positive opinion from the agency and were subsequently approved by the European Commission in January and May 2016, respectively [1].

Samsung Bioepis is working on a pipeline of 13 biosimilar candidates, which, in addition to the biosimilar candidates mentioned above, also includes SB8, a biosimilar referencing Avastin (bevacizumab).

SB3 is the company’s first oncology biosimilar candidate submitted for regulatory review in Europe. If approved, the marketing and distribution of SB3 in Europe will be handled by Merck.

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1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Oct 7]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe

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Source: Samsung Bioepis

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