The FDA has approved Bkemv (eculizumab-aeeb) as the first interchangeable biosimilar to Soliris (eculizumab) to treat certain rare diseases. As an interchangeable biosimilar, Bkemv is highly similar with no clinically meaningful differences to Soliris.
- Bkemv is approved for the following treatment indications, which are also currently approved for
Soliris:
o the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce
hemolysis; and
o the treatment of patients with atypical hemolytic uremic syndrome (aHUS) to inhibit
complement-mediated thrombotic microangiopathy. - Bkemv is available only through a restricted program called the Bkemv Risk Evaluation and Mitigation Strategy (REMS).
Source: FDA
