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Addressing the Regulatory and Scientific Challenges with Generic Orally Inhaled Drug Products

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Abstract

Generic products offer a considerable cost savings for American consumers and the US healthcare industry. While generics for many products have become available, the approval and adoption of generics for orally inhaled drug products (OIDPs) has lagged behind, owing to the difficulties in bringing these complex generic products to the market. As a complex product, OIDP performance is impacted by numerous factors derived from the product’s formulation, delivery to a local site of action within the lung, the performance of the device, and the patient population that uses the medication. Therefore, determining equivalence between generic and brand-name OIDPs requires an approach that considers each of these aspects in order to ensure bioequivalence. FDA’s recommended aggregate weight-of-evidence approach for generic OIDPs provides a paradigm where studies and conditions, when taken together, establish equivalence in device performance, systemic exposure, and local drug delivery. This review article covers the various aspects of OIDP complexity, the challenges each presents to equivalence, and FDA’s efforts to address these challenges and complex drug development as a whole under the Generic Drug User Fee Amendments (GDUFA). The aggregate weight-of-evidence approach, its rationale, and scientific support is also described.

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  1. Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA

    Bryan Newman

  2. Office of Bioequivalence, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA

    Kimberly Witzmann

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Correspondence to Bryan Newman.

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Bryan Newman and Kimberly Witzmann declare that they have no conflict of interest.

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This article reflects the views of Bryan Newman and Kimberly Witzmann and should not be construed to represent the views or policies of the U.S. Food and Drug Administration (FDA or the Agency).

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Newman, B., Witzmann, K. Addressing the Regulatory and Scientific Challenges with Generic Orally Inhaled Drug Products. Pharm Med 34, 93–102 (2020). https://doi.org/10.1007/s40290-020-00327-y

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