Intellectual Property,
Administrative/Regulatory
Mar. 14, 2015
Biosimilar approval a groundbreaking step
The Food and Drug Administration recently approved the first biosimilar drug for use in the United States. By Michelle Rhyu and Susan Krumplitsch
On March 6, nearly five years after the Biologics and Price Control and Innovation Act (BPCIA) was enacted, the federal Food and Drug Administration took a groundbreaking step: It approved the first biosimilar drug for use in the United States. The drug is Sandoz's Zarxio, a white blood cell growth factor primarily used to help prevent infections in cancer patients receiving chemotherapy. Zarxio is a close copy of Amgen...
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