US FDA approves Amgen's biosimilar to AstraZeneca's rare blood disorder treatment

London: 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.

(Reporting by Sneha S K in Bengaluru; Editing by Alan Barona)