The U.S. Food and Drug Administration has granted approval to Bkemv (eculizumab), marking it as the first interchangeable biosimilar to Soliris (eculizumab) for treating specific rare conditions. Bkemv is authorized for the same therapeutic uses as Soliris, which include:-
Both PNH and aHUS are uncommon disorders characterized by the destruction of red blood cells. PNH can lead to anemia (low red blood cell count), thrombosis (blood clots), pancytopenia (low counts of red and white blood cells and platelets), and dark-colored urine. aHUS is associated with anemia, thrombocytopenia (low platelet count), and kidney failure.
Bkemv is a monoclonal antibody that targets the complement C5 protein, preventing activation of the complement system, a part of the immune system. This action inhibits the breakdown of red blood cells within blood vessels (intravascular hemolysis) in patients with PNH and aHUS.
Both Bkemv and Soliris carry a Boxed Warning indicating an increased risk of severe and potentially fatal meningococcal infections caused by Neisseria meningitidis, the bacterium responsible for meningitis and other serious infections. Patients must complete meningococcal vaccination before starting treatment with Bkemv or Soliris. They should also be monitored for early signs and symptoms of meningococcal infections and receive immediate medical evaluation if such symptoms appear.
As an interchangeable biosimilar, Bkemv is highly similar to Soliris, with no clinically significant differences. It has the same safety warnings and is expected to produce similar adverse reactions as Soliris. In clinical trials for PNH, the most common adverse reactions to Soliris (≥10% overall and more frequent than placebo) included headache, nasopharyngitis (common cold), back pain, and nausea.
For aHUS, the most common adverse reactions (≥20%) were headache, diarrhea, hypertension, upper respiratory infection, abdominal pain, vomiting, nasopharyngitis, anemia, cough, swelling of lower legs or hands, nausea, urinary tract infections, and fever.
Bkemv is the 53rd biosimilar approved in the U.S., with 13 of these approved as interchangeable biosimilars. An interchangeable biosimilar can be substituted for the reference product without consulting the prescriber, subject to state pharmacy laws, a practice known as "pharmacy-level substitution," similar to how generic drugs are substituted for brand-name drugs.
FDA stated that the approval of biosimilars and interchangeable biosimilars supports its ongoing efforts to promote a competitive marketplace for biological products and enhance patient access to more affordable treatments.
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