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.
Mylan said it expects to launch Fulphila in the coming weeks.
The partners received a complete response letter for the biosimilar in October. The CRL addressed CMC data concerning requalification of a facility after modifications, and did not pertain to the product's biosimilarity, pharmacokinetics, clinical data or immunogenicity.
Mylan dipped $0.34 to $38.50 on Monday, then gained $2 to $40.50 in after hours trading when the news was announced.
Biocon gained Rs6.20 to Rs655.20 on the National Stock Exchange, and rose Rs5.25 to Rs654.10 on the BSE.