FDA approves first biosimilar to Neulasta (pegfilgrastim)

04 June 2018: FDA approves first biosimilar to Neulasta (pegfilgrastim), Fulphila of Mylan GmbH. This porduct helps to reduce the risk of infection during cancer treatment . The FDA’s approval of Fulphila is based on review of evidence that included extensive structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamic data, clinical immunogenicity data, and other clinical safety and effectiveness data that demonstrates Fulphila is biosimilar to Neulasta. Fulphila has been approved as a biosimilar, not as an interchangeable product.