FDA Approval of Renflexis, a Biosimilar to Remicade

As of the 24th April 2017, the US Food and Drug Administration has approved Samsung Bioepis’ biosimilar version of Remicade (infliximab). The Biologics License Application (BLA) for the infliximab biosimilar candidate, Renflexis (SB2), was submitted to the FDA in May 2016.

Infliximab is a chimeric monoclonal antibody administered intravenously, that is used for treating several chronic inflammatory diseases, such as Chron’s disease, ankylosing spondylitis, psoriasis and rheumatoid arthritis. The antibody works by blocking the effects of tumour necrosis factor alpha (TNF-?). By blocking the action of TNF-alpha, infliximab helps to reduce the signs and symptoms of inflammation in the body.

Similarity between Renflexis and its originator product has been demonstrated for indication and dosing as well as administration, after multiple clinical trials.

Thanks to clinical studies, it has been shown that there are no clinically meaningful differences in safety and efficacy between the two drugs, even though the inactive ingredients do vary between them. According to the FDA, common adverse reactions to the drug include sinusitis, pharyngitis, headache and upper respiratory infections as well as abdominal pain.

Renflexis (infliximab-abda) has now been approved in all eligible indications of the originator product, and is the first Samsung Bioepis product that has been approved for marketing in the US. In terms of medicine access, the biosimilar is to be marketed and distributed in the US by Merck (MSD), while in Europe it will be marketed by Biogen under the name Flixabi.

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June 2017