Samsung Bioepis obtains European Commission approval for Soliris biosimilar

Korea Biomedical Review

30 May 2023 - Samsung Bioepis said that the European Commission has granted marketing authorization for Epysqli, a biosimilar referencing Soliris (eculizumab) for the treatment of adult and children patients with paroxysmal nocturnal haemoglobinuria.

Epysqli is the first haematology biosimilar developed by Samsung Bioepis, and its final marketing authorisation comes nearly two months after the company received a positive opinion from the CHMP under the EMA on 30 March.

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Michael Wonder

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Michael Wonder

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Outcome , Medicine , Europe , Biosimilar