Bioequivalent Trial and Biosimilar Trial Analysis
Due to the increasing cost of drugs in clinical treatment in recent years, generic equivalents of brand - name drugs have been introduced in the global market to alleviate the problem. These drugs have the same bioequivalence as branded products. But what is the meaning of bioequivalence? The United States Food and Drug Administration (FDA) has defined bioequivalence as, "the absence of a significant difference in the rate and extent to which the active ingredient or active moiety in pharmaceutical equivalents or pharmaceutical alternatives becomes available at the site of drug action when administered at the same molar dose under similar conditions in an appropriately designed study." Nowadays, the generic drugs account for more than 65 per cent of the global pharmaceutical market. Thus, because of the importance of generic drugs in healthcare, we must analyze the bioequivalence in the trials carefully.