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

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