ReviewTherapeutic innovation & regulatory science2026
Exploring Additional Strength Biowaiver Perspectives in the ICH M13B Framework for Immediate Release Solid Oral Dosage Forms: Opportunities & Challenges.
Review in Therapeutic innovation & regulatory science, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Not yet cited in PubMed.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
- Erratum issued
Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
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.
Indexed as
Identifiers
41291367What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.