Samsung’s Rheumatoid Biosimilar could now make it to the EU Market

05/04/2016 - 3 minutes

Samsung Bioepis (South Korea) has gotten an approval recommendation from the EMA for one of its 13 in-development biosimilars: Flixabi, a biosimilar of Janssen’s blockbuster Remicade for Inflammatory diseases.

samsung_bioepis_flixabi_biosimilar_emaSamsung Bioepis is a joint venture between Biogen and Samsung BioLogics, a branch of the Korean giant that provides manufacturing services for development of biologicals.

It started developing a biosimilar pipeline back in 2012, for which the company is solely responsible of R&D, clinical trials and manufacture. The parent company Biogen, as well as MSD (Merck&Co), will take care of the commercialization for the ‘first wave‘ of Bioepis’ biosimilars.

One of these is Flixabi (SB2), which has now been recommended for approval by the EMA. The marketing authorization is now in the hands of the European Commission (EC).

The recommendation follows the marketing submission in March 2015, and was based on a phase I and phase III trials that tested the biosimilarity of Flixabi to Janssen’s Remicade.

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