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

By Thomson Reuters May 28, 2024 | 5:08 PM

(Reuters) -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 two rare blood disorders caused when the immune system attacks and damages red blood cells and platelets.

The two disorders – called paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome – can cause anemia and kidney failure, respectively.

The FDA said that Bkemv is an interchangeable biosimilar, meaning that its highly similar with no clinically meaningful differences to Soliris.

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