Novartis finally wins US approval for its generic Neulasta

Nov 05, 2019

Sandoz, a Novartis division, announced that the U.S. Food and Drug Administration approved its biosimilar Ziextenzo (pegfilgrastim-bmez). The drugmaker's biosimilar was originally rejected by the FDA in 2016.\

The biosimilar has been approved and marketed in Europe as Ziextenzo (pegfilgrastim) since 2018. Sandoz intends to launch Ziextenzo in the U.S. as soon as possible this year.

Ziextenzo is indicated to decrease the incidence of infection, as manifested by febrile neutropenia (low white blood cell count with a fever), in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.

The FDA approval of Ziextenzo was based on analytical, preclinical and clinical research, including data from a three-way pharmacokinetics (PK) and pharmacodynamics (PD) study (LA-EP06-104). This study compared Sandoz pegfilgrastim with US-sourced reference pegfilgrastim, Sandoz pegfilgrastim with EU-sourced reference pegfilgrastim, and US-sourced with EU-sourced reference pegfilgrastim. PK and PD similarity were demonstrated in all three comparisons, and no clinically meaningful differences were observed regarding safety and immunogenicity among the treatment groups.

Read the full Novartis release