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Samsung Bioepis’ Soliris Biosimilar Heads For EMA Review

European Agency Accepts Filing For SB12 Eculizumab Candidate

 
• By Dave Wallace

Samsung Bioepis has taken a further step towards registering its SB12 eculizumab biosimilar after its filing for the Soliris rival was accepted for review by the European Medicines Agency.

Eculizumab mab symbol yellow background
Samsung Bioepis has had its eculizumab filing accepted by the EMA • Source: Shutterstock

Samsung Bioepis has moved closer towards registering its SB12 proposed biosimilar version of Soliris (eculizumab) in Europe, after a marketing authorization application for the candidate was accepted for review by the European Medicines Agency.

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