title: Hot Topics in Primary Care: Demystifying the Differences: Follow-on Biologics, Biosimilars, and Generics.
abstract: Sponsors of follow-on biologics can submit their applications for approval by the US Food and Drug Administration (FDA) under 2 distinct pathways. The submission pathway is determined by the pathway previously used by the reference biologic product, which is the biologic product upon which the follow-on product relies for evidence of safety and efficacy.
authors.affiliation: Consulting Associate, Department of Medicine and Department of Community and Family Medicine, Southern Regional Area Health Education Center, Duke University School of Medicine, Durham, NC, USA.
authors.forename: Eugene E
authors.initials: EE
authors.lastname: Wright
authors.affiliation: Texas Diabetes and Endocrinology, Austin, TX, USA.
authors.forename: Thomas C
authors.initials: TC
authors.lastname: Blevins
authors.affiliation: Eli Lilly and Company, Indianapolis, IN, USA.
authors.forename: Beverly
authors.initials: B
authors.lastname: Reed
authors.affiliation: Eli Lilly and Company, Indianapolis, IN, USA.
authors.forename: Roy Daniel
authors.initials: RD
authors.lastname: Pollom
mesh_terms: D059451:Biosimilar Pharmaceuticals / Q000145:classification* / Q000592:standards*; D017277:Drug Approval / Q000379:methods*; D016568:Drugs, Generic / Q000145:classification* / Q000592:standards*; D017408:Guidelines as Topic; D006801:Humans; D011320:Primary Health Care; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D059451:Biosimilar Pharmaceuticals; D016568:Drugs, Generic