EMA CHMP gives nod to Samsung Bioepis’ Epysqli™ eculizumab biosimilar

Mar 30, 2023

EMA recommended granting marketing authorisation for Samsung Bioepis’ Epysqli™ (eculizumab), biosimilar to Alexion’s Soliris®.  Epysqli is indicated for the treatment of adults and children with paroxysmal nocturnal haemoglobinuria.  According to Samsung Bioepis, Epysqli™ is Samsung Bioepis’ first haematology biosimilar to be recommended for approval in Europe.

On 23 February, EU’s CHMP recommended a grant of market authorisation for Bekemv®, Amgen’s eculizumab biosimilar.

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