The FDA approved Amgen’s monoclonal antibody Bkemv as the first interchangeable biosimilar for Alexion’s blockbuster Soliris to treat two types of rare blood diseases, the agency announced late Tuesday.
Bkemv will be able to replace Soliris to treat the rare blood diseases paroxysmal nocturnal hemoglobinuria and hemolytic uremic syndrome, which affects the kidneys and blood clotting functions.
An Amgen spokesperson told Endpoints News that the interchangeable biosimilar will be launched no later than March 2025.
The launch date is the result of a settlement between Amgen and Alexion, which has since been acquired by AstraZeneca, over a patent dispute back in 2019. The settlement ultimately prevented Amgen from launching a biosimilar for Soliris until March 1, 2025.
“We do not have a price to share at this time and look forward to bringing BKEMV to market as soon as possible as a potential new option for U.S. patients living with these life-altering diseases,” the spokesperson said.
Bkemv and Soliris both include boxed warnings that they increase the risk of meningococcal infections and that patients should have completed meningococcal vaccination before starting on the drugs.
Bkemv has the same safety warnings and is expected to have the same adverse reactions as Soliris, including headache, common cold, back pain and nausea, the FDA said.