FDA approves biosimilar infliximab Renflexis

Biosimilars/News | Posted 05/05/2017 post-comment0 Post your comment

Samsung Bioepis announced on 24 April 2017 that the US Food and Drug Administration (FDA) had approved its biosimilar version of Johnson & Johnson and Merck’s Remicade (infliximab).

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Samsung Bioepis (a Biogen and Samsung joint venture) and Merck submitted their Biologics License Application (BLA) to the FDA for the companies’ infliximab biosimilar candidate, Renflexis (SB2), back in May 2016 [1].

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. Rheumatoid arthritis and psoriasis are estimated to affect around 1.3 million and 7.5 million people, respectively, in the US. 

Renflexis (infliximab-abda) has been approved in all eligible indications of the originator product (Remicade). It is the first Samsung Bioepis product approved for marketing in the US. The biosimilar will be marketed and distributed in the US by Merck, which is known as MSD outside of the US and Canada.

Samsung Bioepis has also received approval for its infliximab biosimilar (SB2) in the European Union, where it is called Flixabi [2], and in South Korea, where it is called Renflexis [3].

Renflexis has been approved as a biosimilar, not as an interchangeable product. According to the Biologics Price Competition and Innovation Act of 2009, only a biological that has been approved as interchangeable may be substituted for the reference product without the intervention of the healthcare provider who prescribed the reference product.

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1. GaBI Online - Generics and Biosimilars Initiative. Samsung Bioepis infliximab biosimilar accepted for review by FDA [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 May 5]. Available from: www.gabionline.net/Biosimilars/News/Samsung-Bioepis-infliximab-biosimilar-accepted-for-review-by-FDA
2. GaBI Online - Generics and Biosimilars Initiative. EMA recommends approval of infliximab biosimilar Flixabi [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 May 5]. Available from: www.gabionline.net/Biosimilars/News/EMA-recommends-approval-of-infliximab-biosimilar-Flixabi
3. GaBI Online - Generics and Biosimilars Initiative. Korean approval for infliximab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 May 5]. Available from: www.gabionline.net/Biosimilars/News/Korean-approval-for-infliximab-biosimilar

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Source: Samsung Bioepis, US FDA

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