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An Industry Perspective of the Alternative Methodology Proposed by FDA to Conducting a Comparative Clinical End Point Study for Generic Inhalation Products

Devereux SJ, Brinkley DJ, Edlin C, Kelly M, Kshirsagar R, Mullins LM, Tyrrell J.

Respiratory Drug Delivery 2024. Volume 1, 2024: 88-101.

Abstract:

Since 2019, some product specific guidances (PSG) published by the US Food and Drug Administration (FDA) allowed an alternative approach to a comparative clinical endpoint bioequivalence study for solution based pre-metered dose inhalers (pMDIs). Criteria provided in the revised PSG recommended several techniques to support a weight of evidence approach, but were somewhat vague, and the onus was on the developer to demonstrate credibility. In February 2024, the FDA issued new product specific guidance for two suspension pMDI products that had evolved to provide detailed recommendations for the alternative comparative clinical endpoint approach.

This article provides an overview of our experience in the development and validation of several of the recommended techniques. Our findings are concordant with the alternative bioequivalence recommendations issued in the latest PSG but also support the need for further discussion and evaluation to enable development of high-quality, affordable generic respiratory inhalers under this regulatory pathway.