Bioequivalence Studies
Bioequivalence means that the active ingredient of a generic drug is absorbed into the body at the same rate and in the same amount as in the original product. Bioequivalence of drugs is studied in healthy volunteers. The main bioequivalence criteria are: amount and rate of absorption of the active substance, time to peak plasma concentration, its level, drug distribution in the body, and the route and rate of drug elimination. The investigational drugs are administered in the same doses.
Bioequivalence guarantees that a generic achieves the same therapeutic effect as the original drug. In Russia, drug bioequivalence assessment has for more than ten years been the main requirement of the medical-biological control of generic drugs. Without demonstrated bioequivalence data, a generic is not accepted into the state drug-registration procedure in the Russian Federation. This requirement is set by Federal Law 61-FZ “On the Circulation of Medicines.” At the same time, large-scale and expensive clinical studies need not be carried out, because the efficacy and safety of the active substance are the same as those of the original drug.
Generic (in Russian also “генерик/женерик”), or reproduced drug, is a drug whose patent protection has expired. This largely matches the WHO definition: “By a generic drug is meant a drug that is intended for possible substitution of an innovator drug; it is produced without a licence from the innovator manufacturer and is placed on the market after the expiry of the patent or other exclusive rights.” Developing a new drug requires significant funding and time — from several hundred million dollars up to one billion, and from 5 to 15 years. Beyond developing the formula of the active substance, one must develop the manufacturing technology, assess efficacy and side effects from cell assays to volunteer studies, and run the relevant marketing campaigns. On average, patent protection lasts about 25 years; during the remaining 10–15 years the manufacturer must recover its investment and make a profit, which is why patented drugs are very expensive — though their quality is guaranteed. A generic is much cheaper: the manufacturer does not need to develop the manufacturing technology, does not have to spend on advertising and brand building — names that differ from the known ones by a few letters are perceived as original.
Generic drugs are more accessible to lower-income groups because their price does not include development costs and extensive clinical studies. Nevertheless, generics must meet the same quality, efficacy and safety standards as original drugs. The number of therapeutic-equivalence studies has therefore increased sharply, and they are globally accepted as sufficient to confirm the identity (or close correspondence) of a generic to the original product.
Granconsult performs bioequivalence studies in strict accordance with Good Clinical Practice (GCP) principles and Russian regulations. Our specialists ensure high-quality and timely execution of every stage of the study:
- development of the bioequivalence study protocol
- preparation of supporting documentation (CRF, Investigator’s Brochure, informed consent)
- selection of the clinical site for the bioequivalence study
- monitoring and audit visits to the clinical site
- organization of insurance for volunteers participating in the bioequivalence study
- representation of the company’s interests before the competent authorities
Our pharmaceutical department will help you organize bioequivalence studies — from protocol design and preparation of the documents for the regulator’s clinical-study authorization to writing the final report on the results.