Mylan NV Monday accomplished what others have failed to do – get FDA approval for a Neulasta biosimilar. The licensing of Fulphila (pegfilgrastim-jmbd), co-developed with Biocon Ltd., of Bangalore, India, also scores a first for the FDA, which has been playing catch-up with the EMA’s head start on the biosimilar path. Although the EMA has authorized 43 biosimilars since 2006, it has yet to approve a biosimilar to Amgen Inc.’s Neulasta, which is used to treat neutropenia in patients on chemotherapy in certain types of cancer.