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CHMP positive decision for Bekemv the first eculizumab biosimilar to treat paroxysmal nocturnal haemoglobinuria. - Amgen

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Published:26th Feb 2023

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 and intended for the treatment of adults and children in paroxysmal nocturnal haemoglobinuria (PNH).


Bekemv is a biosimilar medicinal product. It is highly similar to the reference product Soliris (eculizumab), which was authorised in the EU on 20 June 2007. Data show that Bekemv has comparable quality, safety and efficacy to Soliris.

In August 2020 Alexion Pharmaceuticals reached a patent settlement with Amgen over Soliris (eculizumab), Alexion’s antibody treatment for the blood disease PNH. The agreement prevents Amgen’s biosimilar version of Soliris from entering the US market until 2025.

Condition: Paroxysmal Nocturnal Haemoglobinuria
Type: drug

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