FDA Panel Recommends Approval of First Biosimilar Drug
An FDA advisory panel on Wednesday voted 14-0 to recommend the agency approve Novartis AG's version of Amgen's biologic drug Neupogen, paving the way for it to be the first biosimilar approved by the agency. The copycat would be marketed under the name Zarxio.
- "FDA Panel Backs First 'Biosimilar' Drug" (Burton, Wall Street Journal, 1/7).