FDA’s Gottlieb Announces Important Changes to Biosimilar and Biologic Naming

A statement by the Food and Drug Administration (FDA) departing commissioner, Scott Gottlieb, reinforced a key aspect of biosimilar naming and provided important updates to the use of four-digit suffixes for biologics and biosimilars.   In his statement, Dr. Gottlieb said, “In January 2017, the FDA published a guidance document in which we sought to … Continue reading FDA’s Gottlieb Announces Important Changes to Biosimilar and Biologic Naming →