Global harmonization of immediate‐release solid oral drug product bioequivalence recommendations and the impact on generic drug development
Abstract Immediate‐release (IR) solid oral drug products constitute a significant portion of approved drug products and products under development. Bioequivalence (BE) assessment for these oral products is important for establishing therapeutic equivalence for generic products to their respective co...
| Main Authors: | , , , |
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| Format: | Article |
| Language: | English |
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Wiley
2023-12-01
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| Series: | Clinical and Translational Science |
| Online Access: | https://doi.org/10.1111/cts.13670 |
| _version_ | 1797391746084110336 |
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| author | Joseph Kotsybar Susan Hakeem Lei Zhang Wenlei Jiang |
| author_facet | Joseph Kotsybar Susan Hakeem Lei Zhang Wenlei Jiang |
| author_sort | Joseph Kotsybar |
| collection | DOAJ |
| description | Abstract Immediate‐release (IR) solid oral drug products constitute a significant portion of approved drug products and products under development. Bioequivalence (BE) assessment for these oral products is important for establishing therapeutic equivalence for generic products to their respective comparator products. In December 2022, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) published the first new draft guideline on BE for IR solid oral dosage forms (M13A). To support the development of ICH M13A, we comprehensively reviewed the landscape of oral IR products approved by the U.S. Food and Drug Administration (FDA) and compared BE recommendations for these products in the current U.S. FDA and European Medicines Agency (EMA) BE guidances. We utilized databases including Drugs@FDA, Orange Book, and product‐specific guidances (PSGs) published on the U.S. FDA and EMA websites to collect information. Oral IR products account for 46% of all FDA‐approved new drug applications currently listed in Orange Book with 82.5% solids, 0.9% semi‐solids, and 16.6% liquids. For all published U.S. FDA PSGs for solid oral IR products, in vivo BE studies with pharmacokinetic (PK) endpoints account for 88% of BE approaches recommended. Of these PK BE studies, 86.5% recommended fasting and fed BE studies, while only 15.9% EMA PSGs recommended both fasting and fed BE studies. This review helps clarify the scope of U.S. solid oral IR products impacted by the new ICH M13A draft guideline and demonstrates how recommendations in draft ICH M13A could significantly harmonize BE recommendations for IR oral products to facilitate global drug development. |
| first_indexed | 2024-03-08T23:37:08Z |
| format | Article |
| id | doaj.art-c052c06a893d4d469e73a6d98944ef09 |
| institution | Directory Open Access Journal |
| issn | 1752-8054 1752-8062 |
| language | English |
| last_indexed | 2024-03-08T23:37:08Z |
| publishDate | 2023-12-01 |
| publisher | Wiley |
| record_format | Article |
| series | Clinical and Translational Science |
| spelling | doaj.art-c052c06a893d4d469e73a6d98944ef092023-12-14T06:03:04ZengWileyClinical and Translational Science1752-80541752-80622023-12-0116122756276410.1111/cts.13670Global harmonization of immediate‐release solid oral drug product bioequivalence recommendations and the impact on generic drug developmentJoseph Kotsybar0Susan Hakeem1Lei Zhang2Wenlei Jiang3Office of Research and Standards, Office of Generic Drugs Center for Drug Evaluation and Research, U.S. Food and Drug Administration Silver Spring Maryland USAOffice of Research and Standards, Office of Generic Drugs Center for Drug Evaluation and Research, U.S. Food and Drug Administration Silver Spring Maryland USAOffice of Research and Standards, Office of Generic Drugs Center for Drug Evaluation and Research, U.S. Food and Drug Administration Silver Spring Maryland USAOffice of Research and Standards, Office of Generic Drugs Center for Drug Evaluation and Research, U.S. Food and Drug Administration Silver Spring Maryland USAAbstract Immediate‐release (IR) solid oral drug products constitute a significant portion of approved drug products and products under development. Bioequivalence (BE) assessment for these oral products is important for establishing therapeutic equivalence for generic products to their respective comparator products. In December 2022, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) published the first new draft guideline on BE for IR solid oral dosage forms (M13A). To support the development of ICH M13A, we comprehensively reviewed the landscape of oral IR products approved by the U.S. Food and Drug Administration (FDA) and compared BE recommendations for these products in the current U.S. FDA and European Medicines Agency (EMA) BE guidances. We utilized databases including Drugs@FDA, Orange Book, and product‐specific guidances (PSGs) published on the U.S. FDA and EMA websites to collect information. Oral IR products account for 46% of all FDA‐approved new drug applications currently listed in Orange Book with 82.5% solids, 0.9% semi‐solids, and 16.6% liquids. For all published U.S. FDA PSGs for solid oral IR products, in vivo BE studies with pharmacokinetic (PK) endpoints account for 88% of BE approaches recommended. Of these PK BE studies, 86.5% recommended fasting and fed BE studies, while only 15.9% EMA PSGs recommended both fasting and fed BE studies. This review helps clarify the scope of U.S. solid oral IR products impacted by the new ICH M13A draft guideline and demonstrates how recommendations in draft ICH M13A could significantly harmonize BE recommendations for IR oral products to facilitate global drug development.https://doi.org/10.1111/cts.13670 |
| spellingShingle | Joseph Kotsybar Susan Hakeem Lei Zhang Wenlei Jiang Global harmonization of immediate‐release solid oral drug product bioequivalence recommendations and the impact on generic drug development Clinical and Translational Science |
| title | Global harmonization of immediate‐release solid oral drug product bioequivalence recommendations and the impact on generic drug development |
| title_full | Global harmonization of immediate‐release solid oral drug product bioequivalence recommendations and the impact on generic drug development |
| title_fullStr | Global harmonization of immediate‐release solid oral drug product bioequivalence recommendations and the impact on generic drug development |
| title_full_unstemmed | Global harmonization of immediate‐release solid oral drug product bioequivalence recommendations and the impact on generic drug development |
| title_short | Global harmonization of immediate‐release solid oral drug product bioequivalence recommendations and the impact on generic drug development |
| title_sort | global harmonization of immediate release solid oral drug product bioequivalence recommendations and the impact on generic drug development |
| url | https://doi.org/10.1111/cts.13670 |
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