title: The FDA's assessment of follow-on protein products: a historical perspective.
abstract: The scientific and regulatory issues that are associated with the possible introduction of 'follow-on' versions of protein drug products are the topic of considerable debate at present. Because of the differences between protein drug products and small-molecule drugs, the development of follow-on versions of protein products presents more complex scientific challenges than those presented by the development of generic versions of small-molecule drugs. Here, with a view to illustrating the Food and Drug Administration's (FDA's) scientific reasoning and experience in this area, we discuss past examples of the FDA's actions involving the evaluation of various types of follow-on and second-generation protein products and within-product manufacturing changes. The FDA believes its evaluation of the safety and effectiveness of follow-on protein products will evolve as scientific and technological advances in product characterization and manufacturing continue to reduce some of the complexity and uncertainty that are inherent in the manufacturing of protein products.
authors.affiliation: Food and Drug Administration, 5600 Fishers Lane, Rockville, Maryland 20857, USA. janet.woodcock@fda.hhs.gov
authors.forename: Janet
authors.initials: J
authors.lastname: Woodcock
authors.forename: Joseph
authors.initials: J
authors.lastname: Griffin
authors.forename: Rachel
authors.initials: R
authors.lastname: Behrman
authors.forename: Barry
authors.initials: B
authors.lastname: Cherney
authors.forename: Terrie
authors.initials: T
authors.lastname: Crescenzi
authors.forename: Blair
authors.initials: B
authors.lastname: Fraser
authors.forename: Dena
authors.initials: D
authors.lastname: Hixon
authors.forename: Christopher
authors.initials: C
authors.lastname: Joneckis
authors.forename: Steven
authors.initials: S
authors.lastname: Kozlowski
authors.forename: Amy
authors.initials: A
authors.lastname: Rosenberg
authors.forename: Lewis
authors.initials: L
authors.lastname: Schrager
authors.forename: Emily
authors.initials: E
authors.lastname: Shacter
authors.forename: Robert
authors.initials: R
authors.lastname: Temple
authors.forename: Keith
authors.initials: K
authors.lastname: Webber
authors.forename: Helen
authors.initials: H
authors.lastname: Winkle
mesh_terms: D000418:Albumins / Q000592:standards; D000485:Allergens; D002116:Calcitonin / Q000592:standards; D017277:Drug Approval; D000068817:Epoetin Alfa; D004921:Erythropoietin / Q000592:standards; D017325:Hepatitis B Vaccines / Q000592:standards; D006821:Hyaluronoglucosaminidase / Q000592:standards; D011506:Proteins / Q000592:standards*; D011994:Recombinant Proteins / Q000592:standards*; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D000418:Albumins; D000485:Allergens; D017325:Hepatitis B Vaccines; D011506:Proteins; D011994:Recombinant Proteins; D004921:Erythropoietin; D000068817:Epoetin Alfa; C028815:salmon calcitonin; D002116:Calcitonin; D006821:Hyaluronoglucosaminidase