title: Licensing of Generic Medicines: Are There Any Challenges Left? A Pharmaceutical Regulatory Perspective.
abstract: When an innovative product (innovator) is not covered anymore by intellectual property rights, cheaper equivalent medicinal products (generic products) may be marketed and used in clinical practice. The regulation of generic products is well-established, and is primarily based on standard rules for quality, therapeutic equivalence requirements (the latter in most instances proven through a bioequivalence study), and safety data for the innovator. The extensive experience from bringing generic products to the market over the last decades allows the conclusion that they are well-accepted and provide a useful alternative option for cost-effective pharmacotherapy. While supporting this conclusion, there are a number of issues to be considered during the assessment of a generic product application. Six scenarios are described in total, from an efficacy and a safety perspective, where potential concerns with the current regulatory standards could arise in the approval of generic products. We also propose solutions to these scenarios in order to foster debate on these issues.
authors.affiliation: Medicines Authority, 203 Level 3, Rue D'Argens, Gzira, GZR 1368, Malta. ; Department of Biology, School of Pharmacy, University of Tor Vergata, Rome, Italy.
authors.forename: John Joseph
authors.initials: JJ
authors.lastname: Borg
authors.affiliation: European Medicines Agency, 7 Westferry Circus, London E14 4HB, UK.
authors.forename: Paolo
authors.initials: P
authors.lastname: Tomasi
authors.affiliation: Italian Medicines Agency, AIFA, Via del Tritone, 181, 00186 Rome, Italy.
authors.forename: Luca
authors.initials: L
authors.lastname: Pani
authors.affiliation: National Organisation of Medicines (EOF), 284 Messogion STF, 155 62 Athens, Greece.
authors.forename: George
authors.initials: G
authors.lastname: Aislaitner
authors.affiliation: Department of Anaesthesiology and Critical Care Medicine, Postgraduate MedicalSchool, Czerniakowska 231, 00 416 Warsaw, Poland.
authors.forename: Michal
authors.initials: M
authors.lastname: Pirozynski
authors.affiliation: Medicines Evaluation Board (MEB), Graadt van Roggenweg 500, 3531 AH Utrecht, Netherlands.
authors.forename: Hubert
authors.initials: H
authors.lastname: Leufkens
authors.affiliation: Department of Physiology and Pharmacology, University of Rome "Sapienza", Rome, Italy.
authors.forename: Daniela
authors.initials: D
authors.lastname: Melchiorri
keywords: Biocreep; Generics; Off-patent medicines; Regulatory science; Safety of generics; Therapeutic equivalence