Amgen Inc. (NASDAQ: AMGN), a leading biopharmaceutical company, has been granted regulatory approval by the US Food and Drug Administration (FDA) for Bkemv, marking a significant milestone as the first biosimilar in the US to compete with AstraZeneca’s (AZ; NASDAQ: AZN) Soliris (eculizumab). Both the originator drug from AstraZeneca and Amgen’s biosimilar are indicated for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS).
Bkemv has been awarded interchangeable biosimilar status, signifying that it can be substituted for the reference product in certain cases. However, due to the serious safety concerns associated with the biologic, Bkemv will only be made available to patients who have completed a risk evaluation and mitigation strategy (REMS) program.- Flcube.com
