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Times Have Changed: FDA Ends ESA REMS Ahead Of First Biosimilars

 
• By Michael McCaughan

FDA is ending one of the landmark drug safety programs from the REMS era, announcing it has released Amgen from its mandatory obligations for the erythropoiesis-stimulating agent (ESA) class. The decision comes just ahead of the likely approval of the first biosimilar application in the class.

FDA’s decision to end the erythropoiesis-stimulating agent (ESA) class REMS is yet another symbolic milestone for the agency in moving beyond the drug safety debates of the 2000s – and also a timely step to help advance the emerging era of biosimilars.

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