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Sandoz Resubmits BLA For Proposed Biosimilar Pegfilgrastim To FDA - Quick Facts

Sandoz, a Novartis division, announced resubmission of its Biologics License Application (BLA) for a proposed biosimilar pegfilgrastim to the US FDA to address an FDA complete response letter received in June 2016. The resubmission includes new data from a pivotal pharmacokinetics and pharmacodynamics study.

Sandoz said it is pursuing approval of biosimilar pegfilgrastim to decrease the incidence of infection, as manifested by febrile neutropenia (low white blood cell count with a fever), in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. The company said the new data was from a single-dose, three-period cross-over study comparing Sandoz pegfilgrastim with US-sourced reference pegfilgrastim; Sandoz pegfilgrastim with EU-sourced reference pegfilgrastim; and US with EU-sourced reference pegfilgrastim.

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