title: Legislative initiatives in Europe, Canada and the US for market authorization of follow-on biologics.
abstract: The formulation and application of legal and regulatory requirements for the market authorization of follow-on versions of biological drugs present challenges. This review discusses relevant regulatory guidelines and legislative initiatives related to market authorization for follow-on biologics in Europe, Canada and the US. The respective positions of these three markets is analyzed with regard to several factors: criteria for the choice of reference products; requirements for the comparability exercise between a candidate follow-on biologic and the selected reference product, with an emphasis on considerations of quality, safety and efficacy data; the interchangeability of a reference product with related follow-on drugs; data exclusivity provisions; and the application of specialized patent enforcement mechanisms to follow-on biologics.
authors.affiliation: Boehringer Ingelheim Canada Ltd, Research and Development, Laval, QC H7S 2G5, Canada. ylooper@lav.boehringer-ingelheim.com
authors.forename: Ywe J
authors.initials: YJ
authors.lastname: Looper
mesh_terms: D001688:Biological Products / Q000191:economics / Q000592:standards*; D002170:Canada; D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence / Q000592:standards; D017277:Drug Approval / Q000191:economics / Q000331:legislation & jurisprudence*; D015195:Drug Design; D005060:Europe; D017408:Guidelines as Topic / Q000592:standards*; D006801:Humans; D007880:Legislation, Drug; D011358:Product Surveillance, Postmarketing / Q000592:standards*; D014481:United States
chemical_list: D001688:Biological Products