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Bioequivalence Studies: Generic Products

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The ADME Encyclopedia
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Synonyms

Generic medicinal products; Generic products; Multisource pharmaceutical products

Definitions

According to the World Health Organization (WHO), multisource pharmaceutical products or generic products are “pharmaceutically equivalent or pharmaceutically alternative products that may or may not be therapeutically equivalent” [1]. According to that same organization, when multisource pharmaceutical products are therapeutically equivalent, they can be considered interchangeable.

Pharmaceutical alternatives are products that contain the same active pharmaceutical moiety or moieties but differ in dosage form (e.g., tablets versus capsules), strength, and/or the chemical form of the active ingredient(s) (for instance, different salts or different esters) [1, 2]. Pharmaceutical alternatives must deliver the same active moiety by the same route of administration [1]. On the other hand, pharmaceutical equivalentscontain the same molar amount of the same active pharmaceutical...

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References

  1. WHO Expert Committee on Specifications for Pharmaceutical Preparations N° 992. Annex 7 multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability. 2015. Available from: https://www.who.int/medicines/areas/quality_safety/quality_assurance/expert_committee/WHO_TRS_992_web.pdf

  2. European Agency (EMA) Committee for Human Medicinal Products (CHMP). Guideline on the investigation of bioequivalence Doc. Ref.: CPMP/EWP/QWP/1401/98 Rev. 1/ Corr **. 2010. Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-investigation-bioequivalence-rev1_en.pdf

  3. European Agency (EMA) Committee for Human Medicinal Products (CHMP). European Medicines Agency procedural advice for users of the centralised procedure for generic/hybrid applications Doc. Ref. EMEA/CHMP/225411/2006. Available from: https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/european-medicines-agency-procedural-advice-users-centralised-procedure-generic/hybrid-applications_en.pdf.

  4. U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) Guidance for Industry Referencing Approved Drug Products in ANDA Submissions. October 2020. Available from: https://www.fda.gov/media/102360/download

  5. U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Guidance for Industry Bioavailability and Bioequivalence Studies Submitted in NDAs or INDs -General Considerations Draft Guidance. March 2014 Biopharmaceutics. Available from: https://www.fda.gov/files/drugs/published/Bioavailability-and-Bioequivalence-Studies-Submitted-in-NDAs-or-INDs-%E2%80%94-General-Considerations.pdf

  6. European Commission Health and Food Safety Directorate -General. Revision 11 notice to applicants. volume 2A- Procedures for marketing authorization- Chapter a marketing authorization. July 2019. Available from: https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-2/vol2a_chap1_en.pdf

  7. Gothe H, Schall I, Saverno K, Mitrovic M, Luzak A, Brixner D, et al. The impact of generic substitution on health and economic outcomes: a systematic review. Appl Health Econ Health Policy. 2015;13(1):S21–33. https://doi.org/10.1007/s40258-014-0147-0.

    Article  PubMed  Google Scholar 

  8. Ferrario A, et al. Strategies to achieve fairer prices for generic and biosimilar medicines. BMJ. 2020;368:15444. https://doi.org/10.1136/bmj.15444.

    Article  Google Scholar 

  9. Conrad R, Lutter R. Generic competition and drug prices: new evidence linking greater generic competition and lower drug prices report. US. Food and Drug Administration. December 2019. Available from: https://www.fda.gov/media/133509/download

  10. US Food and Drug Administration. Generic drug facts. 2018. Available from: https://www.fda.gov/drugs/generic-drugs/generic-drug-facts

  11. Lionberger R, Jiang W, Huang S-M, Geba G. Confidence in generic drug substitution. Clin Pharmacol Ther. 2013;94(4):438–40. https://doi.org/10.1038/clpt.2013.104.

    Article  CAS  PubMed  Google Scholar 

  12. Yu Y, Teerenstra S, Neef C, Burger D, Maliepard M. Investigation into the interchangeability of generic formulations using immunosuppressants and a broad selection of medicines. Eur J Clin Pharmacol. 2015;71:971–90. https://doi.org/10.1007/s00228-015-1878-z.

    Article  CAS  Google Scholar 

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Correspondence to Pablo A. M. Quiroga .

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Quiroga, P.A.M. (2022). Bioequivalence Studies: Generic Products. In: Talevi, A. (eds) The ADME Encyclopedia. Springer, Cham. https://doi.org/10.1007/978-3-030-84860-6_131

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