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Design Considerations for Alternative Bioequivalence Approaches for Generic Orally Inhaled Drug Products

Newman B.

Respiratory Drug Delivery 2023. Volume , 2023: 149-150.

Abstract:

The US Food and Drug Administration (FDA) provides recommendations for establishing bioequivalence (BE) with local drug delivery for orally inhaled drug products (OIDPs), which often involve study designs for conducting comparative clinical endpoint (CCEP) and pharmacodynamic (PD) BE studies. Considering the challenges that these studies can present for generic drug developers, FDA product-specific guidance (PSG) recommendations for several OIDPs have included alternative BE approaches that do not include conducting CCEP BE studies. However, designing an alternative BE approach for OIDPs with more complex formulations, such as suspension-based metered dose inhalers (MDIs) and dry powder inhalers (DPIs), also presents difficulties.

This presentation will provide an overview of FDA’s current understanding on alternative BE approaches for locally-acting OIDPs, including the challenges and considerations with designing an alternative BE approach for suspension-based MDIs and DPIs.