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EMA recommends approval of etanercept biosimilar Posted 27/11/2015

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].

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References
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

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Source: Biogen, EMA, Samsung Bioepis

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