First Biosimilar Drug Set to Enter US Market

January 16, 2015

(Nature) – After years of debate, the US Food and Drug Administration (FDA) is poised to allow the sale of biosimilars, cheaper versions of complex and expensive biological drugs used to treat conditions such as cancer and autoimmune diseases. On 7 January, an FDA advisory panel decided unanimously that a drug made by Sandoz, the generics arm of Swiss pharmaceutical giant Novartis, should be accepted as a replacement for filgrastim (Neupogen), an immune-boosting drug for people undergoing cancer treatment made by Amgen of Thousand Oaks, California.