EMA recommends approval of etanercept biosimilar

Biosimilares/Novedades | Posted 27/11/2015 post-comment0 Post your comment

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 19 November 2015 that it had recommended granting of marketing authorization for a biosimilar etanercept product (SB4).


The biosimilar etanercept, which will be called Benepali (SB4), is produced by Samsung Bioepis, which is a joint venture between South Korean electronics giant Samsung and biotechnology company Biogen. The drug is a biosimilar of Amgen’s Enbrel (etanercept). Etanercept is a biological drug that treats autoimmune diseases by inhibiting tumour necrosis factor (TNF); a soluble inflammatory cytokine. The positive opinion from EMA’s CHMP recommends approval of Benepali positive opinion for the treatment of rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis and plaque psoriasis.

There are currently no biosimilars of etanercept available on the European market. Biogen expects that, ‘if approved, Benepali could be the first biosimilar of Enbrel granted approval in the EU, as well as the first subcutaneous anti-TNF biosimilar there’. Biogen will be the one to commercialize Benepali (SB2) in Europe. As part of the joint venture agreement Biogen has the rights to commercialize SB2 in both Europe and Japan.

The review of Benepali has been a fast one; Samsung Bioepis submitted its application for biosimilar etanercept on 21 January 2015 [1].

The CHMP opinion states that ‘studies have shown that Benepali has a comparable quality, safety and efficacy profile to Enbrel’. Samsung Bioepis will be required, as with all biologicals, to implement a pharmacovigilance plan as part of the marketing authorization.

The CHMP’s recommendation for Benepali will now be referred to the European Commission, which grants approval for the European Union, Iceland and Norway. The Commission’s final approval is anticipated by February 2016.

Samsung Bioepis had its etanercept biosimilar approved in Korea on 8 September 2015, where it will be called Brenzys [2]. Meanwhile, in October 2015, the US Food and Drug Administration (FDA) accepted Sandoz’s application for approval of its etanercept biosimilar (GP2015) [3].

Related article
Biosimilars of etanercept

1.   GaBI Online - Generics and Biosimilars Initiative. Biosimilar etanercept submitted for approval in EU [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Nov 27]. Available from: www.gabionline.net/Biosimilars/News/Biosimilar-etanercept-submitted-for-approval-in-EU
2.   GaBI Online - Generics and Biosimilars Initiative. Biosimilar etanercept approved in South Korea [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Nov 27]. Available from: www.gabionline.net/Biosimilars/News/Biosimilar-etanercept-approved-in-South-Korea
3.   GaBI Online - Generics and Biosimilars Initiative. FDA accepts application for etanercept biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Nov 27]. Available from: www.gabionline.net/Biosimilars/News/FDA-accepts-application-for-etanercept-biosimilar

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2015 Pro Pharma Communications International. All Rights Reserved.

Source: Biogen, EMA, Samsung Bioepis

comment icon Comments (0)
Post your comment
Related content
La FDA aprueba el biosimilar pegfilgrastim Stimufend
Biosimilares/Novedades Posted 07/10/2022
Most viewed articles
Sobre GaBI
INICIO/Sobre GaBI Posted 06/08/2009
EU guidelines for biosimilars
EMA logo 1 V13C15
INICIO/Directrices Posted 08/10/2010