Sandoz’s Ziextenzo (biosimilar, pegfilgrastim) Receives the US FDA’s Approval to Decrease the Incidence of Febrile Neutropenia

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 first and only company offering physicians long- and short-acting filgrastim biosimilar treatment options in the US
• Ziextenzo (pegfilgrastim-bmez) is a long-acting form of filgrastim, indicated to reduce the incidence of febrile neutropenia in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer therapies and has been approved & marketed in the EU since 2018

Click here to­ read full press release/ article | Ref: Novartis | Image: Glassdoor