Mylan-Biocon combine get USFDA nod for biosimilar pegfilgrastim
The Mylan-Biocon combine have notched up their second biosimilar in the US following the regulatory approval given to Fulphila, Mylan’s biosimilar version of pegfilgrastim, originally sold by Amgen under the brandname Neulasta.
Mylan pipped other competitors in the race for this drug in the US market, when it received the US Food and Drug Administration’s approval for Fulphila, a biosimilar it co-developed with
Biocon. The product is used to treat fever and other signs of infection in patients treated with chemotherapy in certain types of cancer.