FDA panel unanimously backs Novartis' copy of Amgen's Neupogen
By Natalie Grover and Samantha Kareen Nair (Reuters) - A panel to the U.S. Food and Drug Administration unanimously backed the approval of Novartis AG's copy of Amgen Inc's blockbuster cancer drug Neupogen, setting the stage for the regulator's first approval of a biosimilar. The United States has lagged other markets in establishing a regulatory framework for biosimilars, copies of biotech drugs or 'biologics'. Since biologics are made from living cells, creating a copy is an arduous process that brings unpredictable results. Therefore, unlike knockoffs of simple chemical drugs, copies of biologics can only be "similar", never identical. Drugmakers are racing to develop biosimilars, which typically cost 20-30 percent less than their original, as big-ticket patents on biologics expire and cash-strapped healthcare systems look to cut costs. The biosimilar could be priced at the same level as Neupogen, but cost to insurers and consumers would be lower, Novartis executives told the panel. Consensus estimates for Neupogen's U.S. sales already take into account competition from biosimilars and are forecast to drop to about $510 million in 2020 from $853.7 million in 2014, Evercore ISI analysts said in a note. The recommendation from the advisory panel comes two days after an FDA staff review concluded that Novartis' copy should be cleared for all the five indications Neupogen is already approved.] While the FDA is not obligated to follow the panel's recommendation, it typically does. Neupogen prevents infections in breast cancer patients undergoing chemotherapy, which reduces their white blood cells, giving rise to a condition called neutropenia. Sandoz, Novartis' generics arm, plans to launch the drug in the United States under the name "Zarxio". Sandoz is already selling a Neupogen biosimilar in more than 40 countries. While Sandoz's application only asks for biosimilarity, the company hinted at a submission for an interchangeable label, which would encourage wider adoption, Sanford C. Bernstein analyst Aaron Gal said. (Editing by Sriraj Kalluvila)
