Sandoz Receives FDA Approval for Biosimilar of Amgen’s Neulasta

By Emily Forster -

November 7, 2019

Sandoz, a Novartis Company, has received US Food and Drug Administration (FDA) approval for its biosimilar, Ziextenzo (pegfilgrastim-bmez), the biosimilar to Amgen’s Neulasta (pegfilgrastim), for treating febrile neutropenia. Neulasta is one of Amgen’s top-selling product with 2018 global sales of $ 4.475 million.

Sandoz’ biosimilar pegfilgrastim has been approved and marketed in Europe as Ziextenzo (pegfilgrastim) since 2018. Sandoz says it now intends to launch Ziextenzo in the US as soon as possible in 2019. Sandoz currently has its short-acting filgrastim, Zarxio, on the US market.

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. Febrile neutropenia is caused by cytotoxic chemotherapy (i.e., medicines that destroy rapidly growing cells).

Sandoz has four US-approved biosimilars and eight marketed biosimilars globally.

Source: Novartis