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Volume 82
Issue 4
10.3797/scipharm.1312-10
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Scientia Pharmaceutica is published by MDPI from Volume 84 Issue 3 (2016). Previous articles were published by another publisher in Open Access under a CC-BY (or CC-BY-NC-ND) licence, and they are hosted by MDPI on mdpi.com as a courtesy and upon agreement with Austrian Pharmaceutical Society (Österreichische Pharmazeutische Gesellschaft, ÖPhG).
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Article

Licensing of Generic Medicines: Are There Any Challenges Left? A Pharmaceutical Regulatory Perspective

by
John Joseph BORG
1,2,*,
Paolo TOMASI
3,
Luca PANI
4,
George AISLAITNER
5,
Michal PIROZYNSKI
6,
Hubert LEUFKENS
7 and
Daniela MELCHIORRI
8
1
Medicines Authority, 203 Level 3, Rue D’Argens, Gzira, GZR 1368, Malta
2
Department of Biology, School of Pharmacy, University of Tor Vergata, Rome, Italy
3
European Medicines Agency, 7 Westferry Circus, London E14 4HB, UK
4
Italian Medicines Agency, AIFA, Via del Tritone, 181, 00186 Rome, Italy
5
National Organisation of Medicines (EOF), 284 Messogion STF, 155 62 Athens, Greece
6
Department of Anaesthesiology and Critical Care Medicine, Postgraduate MedicalSchool, Czerniakowska 231, 00 416 Warsaw, Poland
7
Medicines Evaluation Board (MEB), Graadt van Roggenweg 500, 3531 AH Utrecht, Netherlands
8
Department of Physiology and Pharmacology, University of Rome “Sapienza”, Rome, Italy
*
Author to whom correspondence should be addressed.
Sci. Pharm. 2014, 82(4), 847-856; https://doi.org/10.3797/scipharm.1312-10
Submission received: 12 December 2013 / Accepted: 22 May 2014 / Published: 22 May 2014
Versions Notes

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.
Keywords: Generics; Therapeutic equivalence; Biocreep; Off-patent medicines; Regulatory science; Safety of generics Generics; Therapeutic equivalence; Biocreep; Off-patent medicines; Regulatory science; Safety of generics

Share and Cite

MDPI and ACS Style

BORG, J.J.; TOMASI, P.; PANI, L.; AISLAITNER, G.; PIROZYNSKI, M.; LEUFKENS, H.; MELCHIORRI, D. Licensing of Generic Medicines: Are There Any Challenges Left? A Pharmaceutical Regulatory Perspective. Sci. Pharm. 2014, 82, 847-856. https://doi.org/10.3797/scipharm.1312-10

AMA Style

BORG JJ, TOMASI P, PANI L, AISLAITNER G, PIROZYNSKI M, LEUFKENS H, MELCHIORRI D. Licensing of Generic Medicines: Are There Any Challenges Left? A Pharmaceutical Regulatory Perspective. Scientia Pharmaceutica. 2014; 82(4):847-856. https://doi.org/10.3797/scipharm.1312-10

Chicago/Turabian Style

BORG, John Joseph, Paolo TOMASI, Luca PANI, George AISLAITNER, Michal PIROZYNSKI, Hubert LEUFKENS, and Daniela MELCHIORRI. 2014. "Licensing of Generic Medicines: Are There Any Challenges Left? A Pharmaceutical Regulatory Perspective" Scientia Pharmaceutica 82, no. 4: 847-856. https://doi.org/10.3797/scipharm.1312-10

APA Style

BORG, J. J., TOMASI, P., PANI, L., AISLAITNER, G., PIROZYNSKI, M., LEUFKENS, H., & MELCHIORRI, D. (2014). Licensing of Generic Medicines: Are There Any Challenges Left? A Pharmaceutical Regulatory Perspective. Scientia Pharmaceutica, 82(4), 847-856. https://doi.org/10.3797/scipharm.1312-10

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