May 29 (Surge Insights) – Amgen (AMGN.O) received approval from the US Food and Drug Administration on Tuesday, opening a new tab The first biosimilar of AstraZeneca’s (AZN.L) Soliris, a therapy for rare blood disorders, is called Bkemv.
The medication made by Amgen will be sold as Bkemv. Biosimilars are nearly exact replicas of intricate biological medications.
A black-box warning on the possibility of life-threatening illnesses brought on by the bacterium Neisseria meningitidis accompanies the approval.
The business said in 2022 that Bkemv had achieved the primary objective of a late-stage research, in which the drug’s immunogenicity and safety were shown to be on par with Soliris.
In 2020, AstraZeneca purchased Soliris, an intravenous injectable, from Alexion Pharmaceuticals for $39 billion.
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Bkemv is authorised for the treatment of two uncommon blood diseases brought on by immune system assaults that destroy platelets and red blood cells.
The conditions known as atypical hemolytic uremic syndrome and paroxysmal nocturnal hemoglobinuria can result in renal failure and anaemia, respectively.
According to the FDA, Bkemv is an interchangeable biosimilar, which means that it is very comparable to Soliris and does not differ significantly from it clinically.
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