First Biosimilar Application Arrives At FDA -- Sandoz's Filgrastim

FDA accepted Sandoz's application for a biosimilar version of filgrastim, the company said Thursday (July 24), touting the first application in the highly watched biosimilar pathway created by the Affordable Care Act. The review, which has about seven-and-a-half months remaining, tees up action on hotly debated aspects of the biosimilar pathway, such as intellectual property disputes, naming, interchangeability and extrapolation. Sandoz seeks to copy Amgen's Neupogen. Sandoz's biosimilar filgrastim, branded as Zarzio, has been marketed in more than 40 other...