FDA approves first Neulasta biosimilar

FDA approved Fulphila pegfilgrastim-jmdb from Mylan N.V. (NASDAQ:MYL) and Biocon Ltd. (NSE:BIOCON; BSE:BIOCON), their biosimilar of neutropenia drug Neulasta from Amgen Inc. (NASDAQ:AMGN). FDA said Fulphila is the first approved biosimilar of the pegylated G-CSF.

Specifically, the drug is approved to decrease the chance of infection as suggested by febrile neutropenia in patients with non-myeloid cancer who are receiving myelosuppressive chemotherapy...