On February 23, 2023, the European Medicines Agency (EMA) adopted a positive opinion for BEKEMV®.  BEKEMV® is a biosimilar candidate referencing Alexion’s biological product SOLIRIS® (eculizumab), which is a recombinant humanized monoclonal IgG2/4κ antibody that binds to the human c5 complement protein.  SOLIRIS® is approved for the treatment of paroxysmal nocturnal haemoglobinuria (PNH).  If approved, BEKEMV® would become the first eculizumab biosimilar to be granted European marketing authorization.

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