Lupin Announces FDA Acceptance of aBLA for Pegfilgrastim Biosimilar
By EsqSocial Corporation 16/06/21
Global pharmaceutical company Lupin Limited recently announced that the U.S. FDA has accepted its aBLA for a proposed pegfilgrastim biosimilar (reference product Neulasta®). Lupin reported that the aBLA submission was supported by similarity data from analytical, pharmacokinetic, pharmacodynamic and immunogenicity studies....
By: Goodwin