Zarxio Becomes First FDA-Approved Biosimilar

March 6, 2015 | The FDA announced today that Novartis' white blood cell-stimulating drug Zarxio, a biosimilar version of Amgen's Neupogen, has received approval for use in all indications already covered by Neupogen, mainly to support the immune system during cancer therapies. While Zarxio was widely expected to receive a go-ahead from the FDA, today's final decision is not only a landmark for increasing competition in the biologics market, but also a first glimpse at how the FDA will treat thorny issues like what uniform names to give biosimilars and whether they need to offer clinical evidence for all the same indications as the off-patent drugs they mimic. Bloomberg