Posted by Michael Wonder on 29 May 2024
FDA approves first interchangeable biosimilar for two rare diseases
28 May 2024 - Today, the US FDA approved Bkemv (eculizumab-aeeb) as the first interchangeable biosimilar to Soliris (eculizumab) to treat certain rare diseases.
Bkemv is approved for the following treatment indications, which are also currently approved for Soliris:
- The treatment of patients with paroxysmal nocturnal hemoglobinuria to reduce hemolysis
- The treatment of patients with atypical hemolytic uremic syndrome to inhibit complement-mediated thrombotic microangiopathy
Read FDA press release
Posted by:
Michael Wonder