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Samsung Bioepis files second biosimilar in Europe

This article was originally published in Scrip

Executive Summary

Samsung Bioepis has filed for marketing authorization of a second biosimilar candidate in Europe. The firm, a joint venture between Samsung Biologics and Biogen Idec, has submitted an application for SB2, its biosimilar version of Johnson & Johnson/Merck & Co's TNF inhibitor Remicade (infliximab), based on a head to head preclinical data package, a head to head Phase I study and a head to head Phase III equivalence trial in patients with moderate to severe rheumatoid arthritis. Remicade is approved for six major inflammatory diseases in Europe, and if approved SB2 could be available for use in all of those indications. It would be commercialized by Biogen Idec. The European Medicines Agency has already accepted Samsung Bioepis's application for SB4, its Enbrel (etanercept) biosimilar candidate. In 2014, global sales of Remicade were $7.2bn, while Enbrel sales reported by Amgen/Pfizer/Takeda were $8.9bn. Celltrion and its partner Hospira have already begun selling their biosimilar infliximab, branded as Remsima and Inflectra, respectively, in Europe.



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