FDA Approves First Biosimilar in US, Expects Other Biosimilars to Be Approved Soon

Food and Drug Administration (FDA) has approved Zarxio^® (filgrastim-sndz) as a biosimilar to Neupogen for the same five indications for which United States-licensed Neupogen^® is approved. The formulation of Zarxio differs from that of US-licensed Neupogen in one inactive component, and a review of evidence demonstrated that “there are no clinically meaningful differences between Zarxio and US-licensed Neupogen” indicates an FDA announcement. FDA also notes that more biosimilar treatment options are expected to be approved in the future, according to a Consumer Update posted to the FDA website. In 2014, FDA released its “Purple Book,” containing documents that list biological products, including all biosimilar and interchangeable biological products licensed by FDA under the Public Health Service Act.