The FDA approved a biosimilar to pegfilgrastim (Neulasta), called LA-EP2006 (pegfilgrastim-bmez; Ziextenzo) to decrease the incidence of infection, exhibited from febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer therapy that is associated with a clinically significant incidence of febrile neutropenia, according to Sandoz, a Novartis division.
The agency based its decision on analytical, preclinical and clinical research, including data from a pivotal three-way pharmacokinetics (PK) and pharmacodynamics (PD) study, called LA-EP06-104 – designed to compare 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.
The company intends to launch LA-EP2006 in the US as soon as possible this year, according to a Sandoz release.
“When a cancer patient with febrile neutropenia gets an infection, it can have serious consequences such as delays or dose reductions of chemotherapy,” Carol Lynch, president of Sandoz Inc, said in the release. “The approval of Ziextenzo expands our oncology portfolio, providing physicians with a long-acting supportive oncology biosimilar option. It builds on the foundation of trust and experience we developed with our short-acting filgrastim Zarxio® – the leading filgrastim by market share in the US – including consistent product supply and reliable patient services.”
Novartis. Sandoz receives US FDA approval for long-acting oncology supportive care biosimilar Ziextenzo™ (pegfilgrastim-bmez). Sandoz. Published November 5, 2019. https://bit.ly/2PP20Nh. Accessed November 5, 2019.