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- The U.S. Food and Drug Administration approved on Tuesday Amgen's Bkemv, the first biosimilar to AstraZeneca's rare blood disorder treatment Soliris.
Amgen's drug will be marketed under the name Bkemv. Biosimilars are close copies of complex biological drugs. The approval comes with a black-box warning about the risk of serious infections caused by a bacteria called neisseria meningitidis.In 2022, the company said that Bkemv met the main goal of a late stage study, where the safety and immunogenicity of the drug was comparable to Soliris.
AstraZeneca acquired the intravenous injection, Soliris, through a $39 billion buyout of Alexion Pharmaceuticals in 2020. Bkemv is approved to treat a rare blood disorder caused when the immune system attacks and damages red blood cells and platelets.It has been our privilege to have the trust and support of our East Coast communities for the last 200 years. Our SaltWire team is always watching out for the place we call home. Our 100 journalists strive to inform and improve our East Coast communities by delivering impartial, high-impact, local journalism that provokes thought and action.
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