title: Regulatory watch: Innovation in biologic new molecular entities: 1986-2014.
authors: US Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, Maryland 20993, USA.
authors: Kathleen L
authors: KL
authors: Miller
authors: US Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, Maryland 20993, USA.
authors: Michael
authors: M
authors: Lanthier
mesh_terms: D001688:Biological Products / Q000592:standards*; D059451:Biosimilar Pharmaceuticals / Q000592:standards; D004059:Diffusion of Innovation; D017277:Drug Approval / Q000331:legislation & jurisprudence / Q000706:statistics & numerical data; D055808:Drug Discovery / Q000331:legislation & jurisprudence / Q000706:statistics & numerical data; D033161:Government Regulation; D007880:Legislation, Drug; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D001688:Biological Products; D059451:Biosimilar Pharmaceuticals
references: Nat Rev Drug Discov. 2012 Jun 01;11(6):426-8
references: 22653202