EMA Adopts Positive Opinion for Bekemv (biosimilar, eculizumab) to Treat Paroxysmal Nocturnal Haemoglobinuria
Shots:
- 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
Click here to read the full press release
Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.
