Sandoz scores FDA approval for Neulasta biosimilar Ziextenzo to treat febrile neutropenia infection

pharmafile | November 6, 2019 | News story | Research and Development, Sales and Marketing |  Amgen, FDA, Neulasta, Sandoz, Ziextenzo, pharma 

The FDA has authorised the availability of Sandoz’s Ziextenzo (pegfilgrastim-bmez), a biosimilar version of Amgen’s Neulasta, it has emerged.

The approval covers the same approved indications as its reference product: decrease the incidence of infection caused by febrile neutropenia – a condition responsible for over 60,000 hospitalisations in the US each year – in patients with non-myeloid malignancies who are receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.

The decision was based on research indicating clinical pharmacokinetic and pharmacodynamics similarity of the therapy to pegfilgrastim, Sandoz pegfilgrastim with EU-sourced reference pegfilgrastim, and US-sourced with EU-sourced reference pegfilgrastim.

“When a cancer patient with febrile neutropenia gets an infection, it can have serious consequences such as delays or dose reductions of chemotherapy,” commented Carol Lynch, President of Sandoz. “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.”

Sandoz confirmed its intention for a US launch of the product “as soon as possible this year”. Ziextenzo already secured approval in Europe back in 2018.

Matt Fellows