Regulatory Approaches and Considerations in Establishing Bioequivalence of Inhaled Compounds

Abstract

To be considered bioequivalent to their branded counterparts, generic drugs must meet the standards for bioequivalence (BE) described by the regulatory agencies. While BE of generic inhalational drugs can be evaluated using a similar approach as that for oral dosage from products or drugs that are delivered systemically, the approach is insufficient to address the complexities of inhalational products (e.g., localized site of action, device-patient interface). Therefore, more considerations are needed and caution should be applied when evaluating BE of inhaled compounds. The purpose of this review is to highlight the considerations and challenges in establishing BE of inhaled compounds by (1) outlining the current regulatory approaches (from Health Canada, the U.S. Food and Drug Administration, and the European Medicines Agency) to assess BE for subsequent entry inhaled products (SEIPs) and (2) reviewing the literature pertaining to testing considerations of SEIPs to establish BE.