A Survey of the Criteria Used for the Selection of Alternative Comparator Products by Participating Regulators and Organizations of the International Pharmaceutical Regulators Programme

  1. Tam, Andrew
  2. Garcia-Arieta, Alfredo
  3. Abalos, Ivana
  4. Agostinho Freitas Fernandes, Eduardo
  5. Mendes Lima Santos, Gustavo
  6. Rodriguez Martinez, Zulema
  7. Divinsky, Milly
  8. Kariv, Rami
  9. Potthast, Henrike
  10. Braddy, April C.
  11. Rodrigues, Clare
  12. Guzman Aurela, Erwin
  13. Carolina Arevalo Gonzalez, Liliana
  14. Gutierres Triana, Diego
  15. Jones, Ben
  16. Ahn, Choongyul
  17. Kim, Hyuna
  18. Kim, So Hee
  19. Kuribayashi, Ryosuke
  20. Myoenzono, Aya
  21. Shimojo, Kohei
  22. van Oudtshoorn, Joy
  23. Bigler, Cornelia
  24. Meincke, Ricarda
  25. Roost, Matthias S.
  26. Walther, Chantal
  27. Hsu, Li-feng
  28. Crane, Christopher
  29. Jarman, Tony

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1000 Titel
  • A Survey of the Criteria Used for the Selection of Alternative Comparator Products by Participating Regulators and Organizations of the International Pharmaceutical Regulators Programme
1000 Autor/in
  1. Tam, Andrew |
  2. Garcia-Arieta, Alfredo |
  3. Abalos, Ivana |
  4. Agostinho Freitas Fernandes, Eduardo |
  5. Mendes Lima Santos, Gustavo |
  6. Rodriguez Martinez, Zulema |
  7. Divinsky, Milly |
  8. Kariv, Rami |
  9. Potthast, Henrike |
  10. Braddy, April C. |
  11. Rodrigues, Clare |
  12. Guzman Aurela, Erwin |
  13. Carolina Arevalo Gonzalez, Liliana |
  14. Gutierres Triana, Diego |
  15. Jones, Ben |
  16. Ahn, Choongyul |
  17. Kim, Hyuna |
  18. Kim, So Hee |
  19. Kuribayashi, Ryosuke |
  20. Myoenzono, Aya |
  21. Shimojo, Kohei |
  22. van Oudtshoorn, Joy |
  23. Bigler, Cornelia |
  24. Meincke, Ricarda |
  25. Roost, Matthias S. |
  26. Walther, Chantal |
  27. Hsu, Li-feng |
  28. Crane, Christopher |
  29. Jarman, Tony |
1000 Erscheinungsjahr 2022
1000 Publikationstyp
  1. Artikel |
1000 Online veröffentlicht
  • 2022-10-08
1000 Erschienen in
1000 Quellenangabe
  • 25:323-339
1000 FRL-Sammlung
1000 Copyrightjahr
  • 2022
1000 Lizenz
1000 Verlagsversion
  • https://doi.org/10.18433/jpps33081 |
1000 Publikationsstatus
1000 Begutachtungsstatus
1000 Sprache der Publikation
1000 Abstract/Summary
  • 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.
1000 Sacherschließung
lokal Therapeutic Equivalency
1000 Fächerklassifikation (DDC)
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