title: Initial steps in the regulation of generic biological drugs: a comparison of U.S. and Canadian regimes.
abstract: Biological drug products are poised to overtake traditional pharmaceuticals as the best selling products in the pharmaceutical industry. Accordingly, both innovator and generic drug companies have a vested interest in the rules and regulations governing the approval and market entry of follow-on ("generic") biologic drug products as well as relevant procedures for litigating disputes involving biologic drug products. The U.S. and Canada both regulate the development and sale of traditional generic drugs through complex legal and regulatory schemes that seek to maintain a balance of interests between the innovator and generic sectors of the pharmaceutical industry. With the continued emergence of biological drugs, both countries have recently set forth legal and regulatory schemes to address the unique issues presented by generic biologic drug products. These issues include the requirements needed to submit an application for a generic biologic; biosimilarity vs. interchangeability designations; market and data exclusivity; and procedures for litigating disputes involving biologic drugs. Like the respective rules governing traditional pharmaceuticals, the recent U.S. and Canadian regulations addressing biological drugs contain both similarities and differences. As such, an understanding of both countries regulatory schemes will help both innovators and generics in decision making and legal strategy related to biological drugs. This article provides a comparative overview of the two systems to assist in such an understanding.
authors.forename: Kenneth J
authors.initials: KJ
authors.lastname: Szeto
authors.forename: Marian
authors.initials: M
authors.lastname: Wolanski
mesh_terms: D001688:Biological Products; D059451:Biosimilar Pharmaceuticals; D002170:Canada; D017277:Drug Approval / Q000331:legislation & jurisprudence; D016568:Drugs, Generic; D006801:Humans; D007880:Legislation, Drug; D010330:Patents as Topic; D014481:United States
chemical_list: D001688:Biological Products; D059451:Biosimilar Pharmaceuticals; D016568:Drugs, Generic