Regulatory Amgen’s Biosimilar of AstraZeneca’s Rare Blood Condition Therapy Gets...

Amgen’s Biosimilar of AstraZeneca’s Rare Blood Condition Therapy Gets Approved by the US FDA


The U.S. Food and Drug Administration has approved Bkemv by Amgen, the first biosimilar to AstraZeneca’s Soliris, used to treat a rare blood condition. Known as Bkemv in the pharmaceutical market, this medicine represents a significant advancement in providing alternatives to complex biological preparations. While its approval has positive aspects, it also includes a black box warning about the potential for severe infection caused by Neisseria meningitidis bacteria.

Research showed that Amgen’s journey to approval saw the success of Bkemv in a late-stage study conducted in 2022, where it demonstrated comparable safety and immunogenicity to Soliris. This accomplishment is even more impressive considering AstraZeneca’s significant investment in acquiring Soliris as part of its $39 billion purchase of Alexion Pharmaceuticals in 2020.

Bkemv’s approval extends to treating two rare blood disorders: paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome. These conditions, resulting from immune system disturbances, destroy red blood cells and platelets, potentially leading to anemia and kidney failure.

The FDA’s decision to categorize Bkemv as an interchangeable biosimilar to Soliris means that the two products are very similar, with no clinically significant differences. This classification is beneficial for informing healthcare providers and patients about this medication’s effectiveness and safety profile.

The FDA’s approval of Amgen’s Bkemv as a biosimilar to AstraZeneca’s Soliris is a major step forward in ensuring that eligible patients with these disorders have the best treatment options. This decision underscores the importance of continued advancements in the development of biopharmaceuticals that can improve disease treatment while maintaining stringent measures to protect patients’ lives from risky treatments.

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