FDA staff recommends Novartis copy of Amgen's Neupogen
By Natalie Grover (Reuters) - Staff reviewers at the U.S. Food and Drug Administration recommended approval of Novartis AG's copy of Amgen Inc's blockbuster cancer drug Neupogen, finding no "clinically meaningful differences" between the two. The Swiss drugmaker's drug is the first to be reviewed in the United States under the so-called biosimilar pathway. Biosimilars, or copies of biotech drugs, are yet to make inroads in the country due to the lack of an established regulatory framework. The injectable biologic prevents infections in breast cancer patients undergoing chemotherapy, which reduces white blood cells, giving rise to a condition called neutropenia. The reviewers recommended that Novartis's copy should be cleared for all five indications for which Neupogen is approved, the FDA said on Monday. (http://1.usa.gov/1DoT7eb) Independent experts are scheduled to meet on Wednesday to recommend whether the copy should be approved. Novartis's generics business, Sandoz, already makes copies of Amgen's Neupogen and sells them under the brand name Zarzio in over 40 countries outside the United States. The country accounted for nearly 84 percent of Neupogen's $1.4 billion in sales in 2013. Teva Pharmaceutical Industries Ltd won FDA approval in 2012 to market a drug that is in many ways a copy of Amgen's Neupogen, but not under the biosimilar pathway. Biologics, made from living cells, have safer profiles and stronger efficacy in treating cancers and immunological diseases, consequently carrying hefty price tags which limits their use. Biosimilars, which typically cost 20-30 percent less than their reference biologic, are expected to account for about one quarter of the $100 billion sales stemming from off-patent biologics by the end of the decade, according to Thomson Reuters BioWorld. However, as biologics are made from living cells, creating a copy is an arduous process with unpredictable results. Therefore, unlike knockoffs of simple chemical drugs, copies of biologics can only be "similar", never identical. The reviewers focused on biosimilarity and not the higher bar of interchangeability or substitutability, Evercore ISI analysts said, setting a possible precedent for other biosimilars in the United States. Drugmakers, including South Korea's Celltrion Inc, are racing to develop biosimilars ahead of the looming expiry of patents on big-ticket biologics as cash-strapped healthcare systems worldwide look to curb spending. Meanwhile, Amgen and Sandoz are embroiled in a legal dispute related to the interpretation of patent litigation provisions of the U.S. biosimilar pathway, first issued in 2012. (Additional reporting by Samantha Kareen Nair in Bengaluru; Editing by Kirti Pandey and Savio D'Souza)
