Abstract
When an innovative (brand-name) drug is going off patent protection, pharmaceutical or generic companies may file an abbreviated new drug application (ANDA) for generic approval. As indicated by the United States Food and Drug Administration (FDA), an approved generic drug can be used as a substitute for the brand-name drug. FDA, however, does not indicate that approved generic drugs of the same brand-name drug can be used interchangeably. As more generic drugs become available in the marketplace, it is a concern whether the approved generic drugs are safe and can be used interchangeably. In this article, we propose two safety margins as new bioequivalence limits for monitoring of drug interchangeability based on a meta-analysis of data obtained from regulatory submissions which have been approved by FDA. In addition to the monitoring of drug interchangeability of generic drugs, the proposed margins can also be extended to address drug interchangeability of biosimilars.
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