Samsung Bioepis' biosimilar to AstraZeneca's Soliris backed for EU approval
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A committee of the European Medicines Agency (EMA) recommended the approval ofÂ Samsung Bioepis'Â Epysqli, aÂ biosimilar ofÂ AstraZeneca's (NASDAQ:AZN) rare disease drugÂ Soliris.
The EMA's Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion forÂ Epysqli to treat adults and children with paroxysmal nocturnal haemoglobinuria (PNH).
The CHMP saidÂ Epysqli is highly similar to the reference product Soliris (eculizumab), which was approved in the EU in June 2007.
The European Commission (EC), which generally follows the opinion of the CHMP, will now make a decision on the application.
PNH is a rare disorder in which red blood cells break apart prematurely.