ARTICLE | Clinical News
FDA approves first Neulasta biosimilar
June 8, 2018 4:46 PM UTC
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...