Saturday, 17 August 2019

FDA approves Pfizer's biosimilar

23 July 2018 | News

Nivestym is expected to be available in the US at a significant discount.

Singapore – US Food and Drug Administration approves Pfizer’s Neupogen biosimilar Nivestym and is expected to hit the market at a significant discount to its reference drug.

The white blood cell stimulator will be available for all eligible indications of Amgen’s Neupogen (filgrastim), such as decreasing the incidence of infection in some cancer patients, after showing “a high degree of similarity” in clinical trials, the drug giant said.

According to Pfizer, Nivestym is expected to be available in the US at a significant discount: to the current wholesale acquisition cost of Neupogen, though the drug will be competing for market share with Novartis’ Neupogen biosimilar Zarxio, which became the first biosimilar to be approved by the US Food and Drug Administration back in March 2015.

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