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<p>In generic drug development, achieving bioequivalence followed by biowaivers for additional strengths are crucial for timely market entry. As per regulatory guidance, bioequivalence must be demonstrated for at least one strength—typically the highest, though sometimes a lower strength is chosen due to safety or tolerability concerns. Biowaivers for other strengths can be granted if specific criteria are met, that includes linear pharmacokinetics, same manufacturing process, proportional formulation composition, and similar dissolution profiles under defined conditions. The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) has introduced harmonized guidance, ICH M13B on biowaiver requirements for additional strengths. This guidance is currently under draft stage and shall be finalized soon. In this context, the present review article outlines the biowaiver criteria mentioned in the ICH M13B guidance and compares with that of requirements in European Medicines Agency (EMA) and the United States Food and Drug Administration (USFDA). This review highlights the advantages and challenges of ICH M13B at each stage: pharmacokinetic linearity, formulation proportionality, and dissolution similarity in comparison with existing requirements. Based on the assessment performed in the manuscript, there are challenges and advantages for additional strength biowaivers for USFDA and EMA. Because of the significant changes in dissolution similarity assessments, this review highlights the rationale, risk and benefit in comparison with previous criterion. Overall, this review article summarizes the current understanding and interpretation of ICH M13B against existing biowaiver criteria and provides a way forward for successful regulatory submissions for additional strength biowaivers.</p>

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Exploring Additional Strength Biowaiver Perspectives in the ICH M13B Framework for Immediate Release Solid Oral Dosage Forms: Opportunities & Challenges

  • 期刊论文

  • 发表日期：

    2025年11月25日

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  • Rajkumar Boddu,
  • Arvind Rachapally,
  • Mohammed Shareef Khan,
  • Sohel Mohammed Khan,
  • Frederico S. Martins,
  • Anuj Kumar Saini,
  • Sivacharan Kollipara

摘要

In generic drug development, achieving bioequivalence followed by biowaivers for additional strengths are crucial for timely market entry. As per regulatory guidance, bioequivalence must be demonstrated for at least one strength—typically the highest, though sometimes a lower strength is chosen due to safety or tolerability concerns. Biowaivers for other strengths can be granted if specific criteria are met, that includes linear pharmacokinetics, same manufacturing process, proportional formulation composition, and similar dissolution profiles under defined conditions. The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) has introduced harmonized guidance, ICH M13B on biowaiver requirements for additional strengths. This guidance is currently under draft stage and shall be finalized soon. In this context, the present review article outlines the biowaiver criteria mentioned in the ICH M13B guidance and compares with that of requirements in European Medicines Agency (EMA) and the United States Food and Drug Administration (USFDA). This review highlights the advantages and challenges of ICH M13B at each stage: pharmacokinetic linearity, formulation proportionality, and dissolution similarity in comparison with existing requirements. Based on the assessment performed in the manuscript, there are challenges and advantages for additional strength biowaivers for USFDA and EMA. Because of the significant changes in dissolution similarity assessments, this review highlights the rationale, risk and benefit in comparison with previous criterion. Overall, this review article summarizes the current understanding and interpretation of ICH M13B against existing biowaiver criteria and provides a way forward for successful regulatory submissions for additional strength biowaivers.