CHMP recommends approval of Epysqli in paroxysmal nocturnal haemoglobinuria.- Samsung Bioepis
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Epysqli (eculizumab), from Samsung Bioepis, intended for the treatment of adults and children with paroxysmal nocturnal haemoglobinuria (PNH).
Epysqli will be available as a 300 mg concentrate for solution for infusion. Eculizumab is a recombinant humanised monoclonal IgG2/4k antibody that binds to the human C5 complement protein and thereby inhibits the activation of terminal complement.
Epysqli is a biosimilar medicinal product. It is highly similar to the reference product Soliris (eculizumab), which was authorised in the EU on 20 June 2007. Data show that Epysqli has comparable quality, safety and efficacy to Soliris (eculizumab).
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