Posted by Michael Wonder on 02 Jun 2021
Lupin announces U.S. FDA acceptance for pegfilgrastim biosimilar application
2 June 2021 - Lupin today announced that the U.S. FDA has accepted the biologics license application for its proposed biosimilar to Neulasta (pegfilgrastim) through a filing using the 351(k) pathway.
The biologics license application submission is supported by similarity data from analytical, pharmacokinetic, pharmacodynamic and immunogenicity studies.
