Sandoz resubmits BLA for Neulasta biosimilar

Sandoz said it resubmitted a BLA to FDA for LA-EP2006 to treat neutropenia in patients with non-myeloid malignancies receiving myelosuppressive drugs. LA-EP2006 is a biosimilar of Neulasta pegfilgrastim from Amgen Inc. (NASDAQ:AMGN).

The resubmission from the Sandoz Inc. generics unit of Novartis AG (NYSE:NVS; SIX:NOVN) includes new PK and PD data from a Phase I crossover study that compared LA-EP2006 with U.S.-sourced and EU-sourced reference Neulasta...