When the Food and Drug Administration (FDA) approved the first biosimilar pegfilgrastim (Mylan’s Fulphila™), it broke precedent in more ways than one. Not only was this the first biosimilar member of the pegfilgrastim class to be approved, but its approval did not require an FDA Advisory Committee recommendation. The FDA has been a bit fuzzy … Continue reading FDA Advisory Committees on Biosimilar Applications: Mylan’s Latest Muddies the Waters Further →