title: Informed by the European Union experience: what the United States can anticipate and learn from the European Union's regulatory approach to biosimilars.
authors: Baruch College, New York, New York, USA. Donna.Gitter@Baruch.cuny.edu
authors: Donna M
authors: DM
authors: Gitter
mesh_terms: D001688:Biological Products / Q000191:economics* / Q000627:therapeutic use; D017046:Cost Savings; D017277:Drug Approval / Q000191:economics / Q000331:legislation & jurisprudence*; D004345:Drug Industry / Q000191:economics / Q000331:legislation & jurisprudence*; D004348:Drug Labeling / Q000191:economics / Q000331:legislation & jurisprudence; D004349:Drug Packaging / Q000191:economics / Q000331:legislation & jurisprudence; D004465:Economic Competition; D005062:European Union / Q000458:organization & administration; D006291:Health Policy; D006801:Humans; D007880:Legislation, Drug; D010330:Patents as Topic / Q000331:legislation & jurisprudence; D011358:Product Surveillance, Postmarketing / Q000191:economics; D012308:Risk Management; D013810:Therapeutic Equivalency; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D001688:Biological Products