FDA approves Mylan/Biocon’s Fulphila®

FDA approves Mylan/Biocon’s pegfilgrastim (Fulphila®) on Mylan’s resubmitted application.  This is a the first US Neulasta® biosimilar approved; the second US biosimilar approved from the Mylan/Biocon portfolio; and the tenth US biosimilar overall.  See related FDA media release here.