title: The first subsequent entry biologic authorized for market in Canada: the story of Omnitrope, a recombinant human growth hormone.
abstract: Omnitrope is the first Subsequent Entry Biologic (SEB)/Similar Biotherapeutic Product (SBP) filed with Health Canada, for purposes of marketing. Health Canada is the home organization of the Regulatory Authority in Canada. As the first SEB to be filed for actual review, it presented unique challenges. While the principles for the review and approval of a SEB were laid out in a "fact sheet" there remained still a guidance to be drafted. The review of the submissions proceeded in parallel with the development of the guideline. This article will provide the details of how the final decision was arrived at and how that decision validated the principles underlying the guidance document, in the absence of direct regulations specifically addressing SEBs in Canada.
authors.affiliation: Biologics and Genetic Therapies Directorate, Health Products and Food Branch, Health Canada, 200 Tunney's Pasture Driveway, Ottawa, Ontario, Canada. agnes.v.klein@hc-sc.gc.ca
authors.forename: Agnes V
authors.initials: AV
authors.lastname: Klein
mesh_terms: D000818:Animals; D002170:Canada; D002986:Clinical Trials as Topic; D004341:Drug Evaluation; D017408:Guidelines as Topic; D019382:Human Growth Hormone / Q000009:adverse effects* / Q000627:therapeutic use*; D006801:Humans; D007880:Legislation, Drug; D012107:Research Design
chemical_list: D019382:Human Growth Hormone