EMA Adopts Positive Opinion for Bekemv (biosimilar, eculizumab) to Treat Paroxysmal Nocturnal Haemoglobinuria
- The EMA’s CHMP has adopted a positive opinion recommending the marketing authorization for Bekemv, a biosimilar candidate referencing Alexion’s Soliris (eculizumab) intended for the treatment of adults and children with PNH
- The results showed that Bekemv has comparable quality, safety, and efficacy to Soliris. If approved, Bekemv will become the first eculizumab biosimilar to receive EU marketing authorization
- Bekemv is a recombinant humanized monoclonal IgG2/4k Ab that binds to the human C5 complement protein and prevents terminal complement activation. It will be available as a 300mg concentrate for solution for infusion
Ref: EMA | Image: EMA
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