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OPINION
Legal, clinical, and ethical issues in bioequivalence research
Yaroslavl State Medical University, Yaroslavl, Russia
Correspondence should be addressed: Elena G. Lileeva
Revolutsionnaya St., 5, Yaroslavl, 150000, Russia; ur.xednay@6002aveelile
Author contribution: Speshilova SA — selection and analysis of literature, writing the text; Lileeva EG — scientific guidance, methodological support, final editing and approval of the text; Sinitsina OA — selection and analysis of literature, text editing.
Real-life clinical practice requires to confirm bioequivalence of medicinal products in everyday settings resulting in adequately assessed effectiveness and tolerability of drugs in diverse patient groups. When the studies are lacking, it cannot be warranted that therapeutic effects or safety profiles of the reproduced drug will be identical to those of original brand medicines, which may decrease the trust of doctors and patients in generics and, as a consequence, limit treatment affordability. Assessment of bioequivalence (or pharmacokinetic equivalence) of medicinal products (drugs) is currently considered one of the main types of biomedical quality control of reproduced (generic) medicines. The Russian pharmaceutical market is heavily dominated by generic drugs, which significantly outnumber original products. Thus, bioequivalence studies are of a huge economic and clinical value.
Keywords: ethical aspects, bioequivalence studies, legal issues