Tags : Ziextenzo

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 demonstrating no differences regarding safety and immunogenicity The addition of long-acting supportive oncology biosimilar will expand Sandoz’s oncology portfolio. Following the approval, Sandoz is the […]Read More

Sandoz’s Ziextenzo (pegfilgrastim) Receives EU Approval for Reduction in Duration

 Shots: The approval is based on non-inferiority data with the reference biologic (Neulasta) showing biosimilarity in terms of safety, efficacy and quality Ziextenzo is a long-lasting form of filgrastim indicated to reduce duration of neutropenia and occurrence of febrile neutropenia in adult treated with cytotoxic (anti-cancer) CT Sandoz has received eight biosimilars approval worldwide, with […]Read More