Samsung Bioepis infliximab biosimilar accepted for review by FDA

Biosimilars/News | Posted 03/06/2016 post-comment0 Post your comment

Samsung Bioepis (a Biogen and Samsung joint venture) and Merck announced on 24 May 2016 that the US Food and Drug Administration (FDA) had accepted for review a Biologics License Application (BLA) submitted by Samsung Bioepis for the companies’ infliximab biosimilar candidate, SB2. V13H09

The product is a biosimilar of Johnson & Johnson and Merck’s Remicade (infliximab). 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.

SB2 is the first Samsung Bioepis biosimilar candidate submitted for review in the US. If approved, the marketing and distribution of SB2 in the US will be handled by Merck, in accordance with a commercialization agreement signed in 2013.

Samsung Bioepis’ BLA for SB2 was based on phase I and phase III clinical studies that tested the biosimilarity of SB2 to Remicade. In a 54-week phase III clinical study, Samsung Bioepis reported that ‘SB2 showed comparable safety and equivalent efficacy to Remicade’. This they claim was ‘evidenced in ACR20 response rate of 65.3% in the SB2 arm versus 69.2% in the Remicade arm, fully supporting the 30-week study results of 64.1% and 66.0%, respectively’. The SB2 study randomized 584 patients with moderate to severe rheumatoid arthritis despite methotrexate therapy across 73 sites in 11 countries [1].

The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended approval of the infliximab biosimilar from Samsung Bioepis on 1 April 2016. In Europe, the biosimilar will be called Flixabi (SB2) [2]. The company has also completed the regulatory process to enable the launch of biosimilar infliximab (Renflexis) in South Korea, where Merck will commercialize the product [3].

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1. GaBI Online - Generics and Biosimilars Initiative. Candidate infliximab biosimilar SB2 equivalent to Remicade []. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Jun 3]. Available from:
2. GaBI Online - Generics and Biosimilars Initiative. EMA recommends approval of infliximab biosimilar Flixabi []. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Jun 3]. Available from:
3. GaBI Online - Generics and Biosimilars Initiative. Samsung Bioepis to launch infliximab biosimilar in South Korea []. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Jun 3]. Available from:

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Source: Merck, Samsung Bioepis

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