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Licensing of Generic Medicines: Are There Any Challenges Left? A Pharmaceutical Regulatory Perspective
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...
Autores principales: | , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Scientia Pharmaceutica
2014
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4475802/ https://www.ncbi.nlm.nih.gov/pubmed/26171329 http://dx.doi.org/10.3797/scipharm.1312-10 |
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author | Borg, John Joseph Tomasi, Paolo Pani, Luca Aislaitner, George Pirozynski, Michal Leufkens, Hubert Melchiorri, Daniela |
author_facet | Borg, John Joseph Tomasi, Paolo Pani, Luca Aislaitner, George Pirozynski, Michal Leufkens, Hubert Melchiorri, Daniela |
author_sort | Borg, John Joseph |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-4475802 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2014 |
publisher | Scientia Pharmaceutica |
record_format | MEDLINE/PubMed |
spelling | pubmed-44758022015-07-13 Licensing of Generic Medicines: Are There Any Challenges Left? A Pharmaceutical Regulatory Perspective Borg, John Joseph Tomasi, Paolo Pani, Luca Aislaitner, George Pirozynski, Michal Leufkens, Hubert Melchiorri, Daniela Sci Pharm Research Article 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. Scientia Pharmaceutica 2014-05-22 2014 /pmc/articles/PMC4475802/ /pubmed/26171329 http://dx.doi.org/10.3797/scipharm.1312-10 Text en © Borg et al.; licensee Österreichische Apotheker-Verlagsgesellschaft m. b. H., Vienna, Austria. http://creativecommons.org/licenses/by/4.0/ This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | Research Article Borg, John Joseph Tomasi, Paolo Pani, Luca Aislaitner, George Pirozynski, Michal Leufkens, Hubert Melchiorri, Daniela Licensing of Generic Medicines: Are There Any Challenges Left? A Pharmaceutical Regulatory Perspective |
title | Licensing of Generic Medicines: Are There Any Challenges Left? A Pharmaceutical Regulatory Perspective |
title_full | Licensing of Generic Medicines: Are There Any Challenges Left? A Pharmaceutical Regulatory Perspective |
title_fullStr | Licensing of Generic Medicines: Are There Any Challenges Left? A Pharmaceutical Regulatory Perspective |
title_full_unstemmed | Licensing of Generic Medicines: Are There Any Challenges Left? A Pharmaceutical Regulatory Perspective |
title_short | Licensing of Generic Medicines: Are There Any Challenges Left? A Pharmaceutical Regulatory Perspective |
title_sort | licensing of generic medicines: are there any challenges left? a pharmaceutical regulatory perspective |
topic | Research Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4475802/ https://www.ncbi.nlm.nih.gov/pubmed/26171329 http://dx.doi.org/10.3797/scipharm.1312-10 |
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