title: Implications of the FDA draft guidance on biosimilars for clinicians: what we know and don't know.
authors.affiliation: Department of Pharmacy Practice at the University of New England College of Pharmacy, in Portland, Maine, USA.
authors.forename: Edward
authors.initials: E
authors.lastname: Li
authors.forename: James M
authors.initials: JM
authors.lastname: Hoffman
mesh_terms: D059451:Biosimilar Pharmaceuticals / Q000493:pharmacokinetics / Q000627:therapeutic use*; D017277:Drug Approval / Q000379:methods; D057915:Drug Substitution; D007722:Health Knowledge, Attitudes, Practice; D006284:Health Plan Implementation / Q000331:legislation & jurisprudence / Q000379:methods; D006801:Humans; D056687:Off-Label Use / Q000331:legislation & jurisprudence; D010820:Physicians / Q000331:legislation & jurisprudence; D017410:Practice Guidelines as Topic; D058028:Research Report; D013810:Therapeutic Equivalency; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence*
chemical_list: D059451:Biosimilar Pharmaceuticals