HQ Team
May 30, 2024: The US drug regulator has approved Amen’s biosimilar, Bkemv, to treat rare blood disorders, according to a statement from the Food and Drug Administration.
Bkemv is the first biosimilar to AstraZeneca’s Soliris used for the same treatment. Biosimilars are biological products that are almost a copy of the original and can be manufactured by a new company when the patent expires.
The drug eculizumab-aeeb, marketed by Amgen as Bkemv, is used to reduce hemolysis or the destruction of red blood cells — erythrocytes. It is also used to treat hemolytic uremic syndrome — a condition that can occur when small blood vessels become damaged and inflamed.
The damage can cause clots to form in the vessels in the body. The clots can damage the kidneys and other organs.
Boxed warning
Bkemv, like Soliris, has a boxed warning that states that eculizumab products increase the risk of serious and life-threatening meningococcal infections caused by Neisseria meningitidis, the bacteria that causes meningitis and other potentially severe infections.
Patients should have completed meningococcal vaccination before starting Bkemv or Soliris, be monitored for early signs and symptoms of meningococcal infections and undergo further evaluation immediately if signs of infection develop, according to the FDA statement.
“As an interchangeable biosimilar, Bkemv is highly similar with no clinically meaningful differences to Soliris. Bkemv has the same safety warnings and is expected to have the same adverse reactions as Soliris.”
Bkemv is the 53rd approved biosimilar in the US. The FDA has approved 13 of these as interchangeable biosimilars. AstraZeneca acquired the intravenous injection, Soliris, through a $39 billion acquisition of Alexion Pharmaceuticals in 2020.
