With FDA Recommendation, Novartis Heads for First Approval of a Biosimilar

January 5, 2014 | In advance of a final decision to be handed down January 7, the FDA today announced that staff reviewers have recommended approval of a biologic made by Novartis that imitates Amgen's off-patent Neupogen. Neupogen is used to recover white blood cells during chemotherapy or other immune-compromising treatments; the Novartis version of the drug is the first biologic submitted for approval under new rules for "biosimilars" created in the 2010 Affordable Care Act. The Novartis biosimilar has been submitted for five indications, and if approved will become the first biosimilar cleared for sale in the U.S. through the ACA's accelerated path. Reuters