A Survey of the Criteria Used for the Selection of Alternative Comparator Products by Participating Regulators and Organizations of the International Pharmaceutical Regulators Programme
The safety and efficacy of a generic product are partly based on demonstrating bioequivalence to the innovator product; however, when the innovator product is no longer available as a comparator product, a survey conducted within the Bioequivalence Working Group for Generics (BEWGG) of the Internat...
| Main Authors: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Frontiers Media S.A.
2022-10-01
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| Series: | Journal of Pharmacy & Pharmaceutical Sciences |
| Online Access: | https://journals.library.ualberta.ca/jpps/index.php/JPPS/article/view/33081 |
| _version_ | 1827163279728836608 |
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| author | Andrew Tam Alfredo Garcia-Arieta Ivana Abalos Eduardo Agostinho Freitas Fernandes Gustavo Mendes Lima Santos Zulema Rodriguez Martinez Milly Divinsky Rami Kariv Henrike Potthast April C. Braddy Clare Rodrigues Erwin Guzman Aurela Liliana Carolina Arevalo Gonzalez Diego Gutierres Triana Ben Jones Choongyul Ahn Hyuna Kim So Hee Kim Ryosuke Kuribayashi Aya Myoenzono Kohei Shimojo Joy van Oudtshoorn Cornelia Bigler Ricarda Meincke Matthias S. Roost Chantal Walther Li-feng Hsu Christopher Crane Tony Jarman |
| author_facet | Andrew Tam Alfredo Garcia-Arieta Ivana Abalos Eduardo Agostinho Freitas Fernandes Gustavo Mendes Lima Santos Zulema Rodriguez Martinez Milly Divinsky Rami Kariv Henrike Potthast April C. Braddy Clare Rodrigues Erwin Guzman Aurela Liliana Carolina Arevalo Gonzalez Diego Gutierres Triana Ben Jones Choongyul Ahn Hyuna Kim So Hee Kim Ryosuke Kuribayashi Aya Myoenzono Kohei Shimojo Joy van Oudtshoorn Cornelia Bigler Ricarda Meincke Matthias S. Roost Chantal Walther Li-feng Hsu Christopher Crane Tony Jarman |
| author_sort | Andrew Tam |
| collection | DOAJ |
| description |
The safety and efficacy of a generic product are partly based on demonstrating bioequivalence to the innovator product; however, when the innovator product is no longer available as a comparator product, a survey conducted within the Bioequivalence Working Group for Generics (BEWGG) of the International Pharmaceutical Regulators Programme (IPRP) indicated that the criteria for selecting an alternative comparator product varies. For most members of the BEWGG, an existing marketed generic that was approved based on a comparison with the locally registered innovator product can be used, contingent on criteria that ranges from allowing any generic to be used, to allowing only specific criteria-defined generics to be used. Notwithstanding the acceptability of a generic as an alternative comparator, it is not always the preferred comparator for several jurisdictions. Some jurisdictions require the use of a locally sourced alternative innovator comparator (e.g., the same medicinal ingredient manufactured by a different company) or a foreign innovator comparator. Unlike the other members of the BEWGG, the European Union (EU) has no such options available, rather mechanisms are in place to allow manufacturers to develop a new comparator. The criteria described herein regarding the use of an alternative comparator product can also be applied to scenarios where a specific strength of a series of strengths or an innovative fixed dose combination are discontinued. The results of the survey demonstrate that while criteria for selecting alternative comparator products are not harmonized among the BEWGG participants, the common concern for all jurisdictions is to select a comparator product that meets the safety and efficacy standards of the original innovator product.
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| first_indexed | 2024-03-12T10:04:18Z |
| format | Article |
| id | doaj.art-58dad53dc6254587be848657ec85531f |
| institution | Directory Open Access Journal |
| issn | 1482-1826 |
| language | English |
| last_indexed | 2025-03-21T00:58:11Z |
| publishDate | 2022-10-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Journal of Pharmacy & Pharmaceutical Sciences |
| spelling | doaj.art-58dad53dc6254587be848657ec85531f2024-08-03T04:40:10ZengFrontiers Media S.A.Journal of Pharmacy & Pharmaceutical Sciences1482-18262022-10-012510.18433/jpps33081A Survey of the Criteria Used for the Selection of Alternative Comparator Products by Participating Regulators and Organizations of the International Pharmaceutical Regulators ProgrammeAndrew Tam0Alfredo Garcia-Arieta1Ivana Abalos2Eduardo Agostinho Freitas Fernandes3Gustavo Mendes Lima Santos4Zulema Rodriguez Martinez5Milly Divinsky6Rami Kariv7Henrike Potthast8April C. Braddy9Clare Rodrigues10Erwin Guzman Aurela11Liliana Carolina Arevalo Gonzalez12Diego Gutierres Triana13Ben Jones14Choongyul Ahn15Hyuna Kim16So Hee Kim17Ryosuke Kuribayashi18Aya Myoenzono19Kohei Shimojo20Joy van Oudtshoorn21Cornelia Bigler22Ricarda Meincke23Matthias S. Roost24Chantal Walther25Li-feng Hsu26Christopher Crane27Tony Jarman28Health CanadaAEMPS, Spain; WHO-ObserverANMAT, ArgentinaANVISA, BrazilANVISA, BrazilCOFEPRIS, MexicoCPED, IsraelCPED, IsraelEC, Europe; BfArM, GermanyFDA, United StatesHSA, SingaporeINVIMA, ColombiaINVIMA, ColombiaINVIMA, ColombiaMedsafe, New ZealandMFDS, Republic of KoreaMFDS, Republic of KoreaMFDS, Republic of KoreaMHLW/PMDA, JapanMHLW/PMDA, JapanMHLW/PMDA, JapanSAHPRA, South AfricaSwissmedic, SwitzerlandSwissmedic, SwitzerlandSwissmedic, SwitzerlandSwissmedic, SwitzerlandTFDA, Chinese TaipeiTGA, AustraliaTGA, Australia The safety and efficacy of a generic product are partly based on demonstrating bioequivalence to the innovator product; however, when the innovator product is no longer available as a comparator product, a survey conducted within the Bioequivalence Working Group for Generics (BEWGG) of the International Pharmaceutical Regulators Programme (IPRP) indicated that the criteria for selecting an alternative comparator product varies. For most members of the BEWGG, an existing marketed generic that was approved based on a comparison with the locally registered innovator product can be used, contingent on criteria that ranges from allowing any generic to be used, to allowing only specific criteria-defined generics to be used. Notwithstanding the acceptability of a generic as an alternative comparator, it is not always the preferred comparator for several jurisdictions. Some jurisdictions require the use of a locally sourced alternative innovator comparator (e.g., the same medicinal ingredient manufactured by a different company) or a foreign innovator comparator. Unlike the other members of the BEWGG, the European Union (EU) has no such options available, rather mechanisms are in place to allow manufacturers to develop a new comparator. The criteria described herein regarding the use of an alternative comparator product can also be applied to scenarios where a specific strength of a series of strengths or an innovative fixed dose combination are discontinued. The results of the survey demonstrate that while criteria for selecting alternative comparator products are not harmonized among the BEWGG participants, the common concern for all jurisdictions is to select a comparator product that meets the safety and efficacy standards of the original innovator product. https://journals.library.ualberta.ca/jpps/index.php/JPPS/article/view/33081 |
| spellingShingle | Andrew Tam Alfredo Garcia-Arieta Ivana Abalos Eduardo Agostinho Freitas Fernandes Gustavo Mendes Lima Santos Zulema Rodriguez Martinez Milly Divinsky Rami Kariv Henrike Potthast April C. Braddy Clare Rodrigues Erwin Guzman Aurela Liliana Carolina Arevalo Gonzalez Diego Gutierres Triana Ben Jones Choongyul Ahn Hyuna Kim So Hee Kim Ryosuke Kuribayashi Aya Myoenzono Kohei Shimojo Joy van Oudtshoorn Cornelia Bigler Ricarda Meincke Matthias S. Roost Chantal Walther Li-feng Hsu Christopher Crane Tony Jarman A Survey of the Criteria Used for the Selection of Alternative Comparator Products by Participating Regulators and Organizations of the International Pharmaceutical Regulators Programme Journal of Pharmacy & Pharmaceutical Sciences |
| title | A Survey of the Criteria Used for the Selection of Alternative Comparator Products by Participating Regulators and Organizations of the International Pharmaceutical Regulators Programme |
| title_full | A Survey of the Criteria Used for the Selection of Alternative Comparator Products by Participating Regulators and Organizations of the International Pharmaceutical Regulators Programme |
| title_fullStr | A Survey of the Criteria Used for the Selection of Alternative Comparator Products by Participating Regulators and Organizations of the International Pharmaceutical Regulators Programme |
| title_full_unstemmed | A Survey of the Criteria Used for the Selection of Alternative Comparator Products by Participating Regulators and Organizations of the International Pharmaceutical Regulators Programme |
| title_short | A Survey of the Criteria Used for the Selection of Alternative Comparator Products by Participating Regulators and Organizations of the International Pharmaceutical Regulators Programme |
| title_sort | survey of the criteria used for the selection of alternative comparator products by participating regulators and organizations of the international pharmaceutical regulators programme |
| url | https://journals.library.ualberta.ca/jpps/index.php/JPPS/article/view/33081 |
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