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Amgen Achieves A First With European Eculizumab Nod

Bekemv Biosimilar Rival To Soliris Receives Positive Opinion From EMA’s CHMP

 
• By Dave Wallace

Amgen has received a positive opinion from the EMA’s CHMP recommending that its Bekemv eculizumab biosimilar become the first Soliris rival to be granted a pan-European marketing authorization.

EMA
The EMA’s CHMP has endorsed Amgen’s eculizumab rival

Amgen has notched up a European biosimilar first, after the Committee for Medicinal Products for Human Use within the European Medicines Agency recommended granting a pan-European marketing authorization for the company’s Bekemv biosimilar rival to Soliris (eculizumab).

The European Commission typically acts within 67 days to convert CHMP positive opinions into marketing authorizations.

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