Biosimilars
Regulatory
Sandoz’s Ziextenzo (biosimilar, pegfilgrastim) Receives the US FDA’s Approval to
Shots: The FDA’s approval is based on three-way PK/PD study (LA-EP06-104) assessing Sandoz pegfilgrastim vs US-sourced reference pegfilgrastim, Sandoz pegfilgrastim vs EU-sourced reference pegfilgrastim, and US-sourced vs EU-sourced reference pegfilgrastim […]readmore