Skip to content
Subscriber Only

First Biosimilar Gets FDA Staff Nod as Amgen Drug Draws Imitator

The first attempt in the U.S. to bring to market cheaper imitations of expensive biologic drugs gained support from U.S. regulators.

Novartis AG’s imitation, or biosimilar, is “highly similar” to Amgen Inc.’s blockbuster cancer medicine Neupogen, Food and Drug Administration staff said today in a report. FDA advisers will consider the report when they meet Jan. 7 to make a recommendation on whether the biosimilar should be approved for all five conditions Neupogen is sold to treat, most which help increase the white cell blood count of cancer patients.