Posted by Michael Wonder on 03 Apr 2019
Sandoz resubmits biosimilar pegfilgrastim application to US FDA
2 April 2019 - Sandoz pursues US approval for biosimilar pegfilgrastim, a long-acting version of supportive oncology medicine filgrastim.
Sandoz today announced resubmission of its biologics license application 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. This was 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.
