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FDA Product Specific Guidances: Alternative Bioquivalence Approaches for Orally Inhaled Drug Products

Manzano Jurado N, Silva L.

RDD Asia 2024. Volume 1, 2024: 65-71.

Abstract:

Bioequivalence (BE) ensures that generic drugs perform equally or similarly to their reference listed drugs (RLDs) in terms of active ingredient release rate when taken under the same conditions. Traditional BE assessments rely on comparative clinical endpoint (CCEP) or pharmacodynamic (PD) studies, which present challenges for complex formulations such as pressurized metered dose inhalers (pMDIs) and dry powder inhalers (DPIs). Recent US Food and Drug Administration (FDA) draft product specific guidance (PSG) advocate for alternative BE approaches that integrate advanced in vitro, in vivo and in silico studies, emphasizing realistic aerodynamic particle size distribution (rAPSD) and dissolution as pivotal evidence, particle morphology as a supportive study in assessing performance indicators, and in silico studies as supportive evidence to predict local regional drug deposition in the lungs. By adopting an alternative approach, the approval process for generic orally inhaled drug products (OIDPs) can address the challenges that generic complex drug developers currently face, such as lengthy and costly development and could potentially expedite the approval process, making essential medications more affordable and accessible to patients while maintaining regulatory compliance.