EMA recommends approval of infliximab biosimilar Flixabi

Biosimilars/News | Posted 08/04/2016 post-comment0 Post your comment

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 1 April 2016 that it had recommended granting of marketing authorization for a biosimilar infliximab product (SB2).

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Infliximab is a chimeric monoclonal antibody against tumour necrosis factor alpha (TNF-α). It is used to treat autoimmune diseases, such as ankylosing spondylitis, Crohn’s disease, psoriasis, psoriatic arthritis, rheumatoid arthritis and ulcerative colitis.

The biosimilar infliximab, which will be called Flixabi (SB2), 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 Johnson & Johnson and Merck’s Remicade (infliximab). The patents on Remicade expired in Europe in February 2015 and will expire in the US in September 2018 [1].

The positive opinion from EMA’s CHMP recommends approval of Flixabi for the same indications as Remicade, i.e. ankylosing spondylitis, Crohn’s disease, psoriasis, psoriatic arthritis, rheumatoid arthritis and ulcerative colitis.

The positive CHMP opinion on Flixabi was based on phase I and phase III clinical studies that tested the biosimilarity of Flixabi compared to Remicade. In a 54-week phase III clinical study, Flixabi showed comparable safety and equivalent efficacy to Remicade, with respect to ACR20 response rates, which were 65.3% in the Flixabi arm versus 69.2% in the Remicade arm at Week 54, fully supporting the 30-week study results of 64.1% and 66.0%, respectively. The Flixabi study randomized 584 patients with moderate to severe rheumatoid arthritis despite methotrexate therapy across 73 sites in 11 countries.

Flixabi is the second biosimilar developed by Samsung Bioepis to receive a positive recommendation for approval in Europe. The company received a positive opinion for its etanercept biosimilar, Benepali (SB4), in November 2015 and received final European Union (EU) approval in January 2016 [2].

Samsung Bioepis is working on a pipeline of 13 biosimilar candidates, which include SB5, a candidate biosimilar referencing Humira (adalimumab); SB9 (MK-1293) referencing Lantus (insulin glargine); SB3 referencing Herceptin (trastuzumab); and SB8 referencing Avastin (bevacizumab).

If and when marketing authorization is granted, Flixabi will be commercialized in the EU by Biogen.

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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. EMA recommends approval of etanercept biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Apr 8]. Available from: www.gabionline.net/Biosimilars/News/EMA-recommends-approval-of-etanercept-biosimilar

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Source: EMA, Samsung Bioepis

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