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Biosimilars Law Blog

Tag Archives: epoetin-alpha

Posted in Global Comparisons

Global Dis-Harmonization of Biosimilar Naming and Labeling

The Food and Drug Law Institute held a recent “Dialogue” on the naming and labeling of biosimilars in the U.S. as the Food and Drug Administration (FDA) implements the abbreviated pathway for biosimilars authorized under the Biologics Price Competition and Innovation Act. While the representatives from FDA participated on both panels—naming and labeling, the remainder