Therapeutic equivalence of medications refers to the achievement of clinically comparable therapeutic effect and indicators of efficacy and safety when using medications for medical use that have one international non-proprietary name (or chemical, or grouping), in equivalent dosages for the same indications for use, with the same method of administration in the same group of patients.

Therapeutic Equivalence and Biogenerics

The outcomes of clinical trials to demonstrate equivalence continue to have some significance despite the significance of bioequivalence indicators in the registration of a generic drug. Therapeutic equivalence studies are one of the requirements for registration for analogues of pharmaceuticals with biological origin (biogenerics). Biologically derived substances include hormones, cytokines, blood clotting factors, monoclonal antibodies, enzymes, vaccines, and substances derived from cells and tissues, among others. Since several original biological products (low molecular weight heparains) have patents that are about to expire, these medications will start to show up on the market more frequently in the near future.

Despite the much more complex chemical structure and manufacturing technology of biogenerics, some pharmaceutical companies that produce traditional generics have started to develop them. Bioequivalence studies are insufficient for biological drugs because biogenerics are difficult to accurately characterize due to their complex three-dimensional spatial structure, which makes it difficult to determine their amount in biological fluids (blood, plasma, etc.). This forces regulatory authorities to require biogeneric drug manufacturers to conduct preclinical (toxicological, pharmacodynamic, and pharmacokinetic) and clinical studies (full presentation of data on the efficacy and safety of the drug), as well as data on the study of immunogenicity. As a result, biogenerics have been the subject of therapeutic equivalence studies. The Bioequivalence Center is equipped with all the tools necessary to conduct full-cycle therapeutic equivalence studies.

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Despite the importance of bioequivalence indicators in the registration of a generic drug, the results of clinical trials to prove equivalence remain of some importance.

This applies to analogues of pharmaceuticals of biological origin (biogenerics), for which therapeutic equivalence studies are one of the conditions for registration.

Biological drugs include hormones, cytokines,blood clotting factors, monoclonal antibodies, enzymes, vaccines and drugs based on cells and tissues, etc.

In the near future, such drugs will appear on the pharmaceutical market more often, since the validity of patents for a number of original biological products (small molecular weight heparains) run out.

Some pharmaceutical companies that produce classic generics have begun to develop biogenerics, despite the fact that the chemical structure and technology for producing biogenerics is much more complicated.

Since biogenerics have a complex three-dimensional spatial structure, their amount in biological fluids (blood, plasma, etc.) is difficult to accurately characterize, so bioequivalence studies are not enough for biological drugs. This forces regulatory authorities to require manufacturers of biogenerics to conduct both preclinical (toxicological, pharmacodynamic and pharmacokinetic ) and clinical studies (complete presentation of data on the efficacy and safety of the drug), as well as data on the study of immunogenicity.

Therefore, therapeutic equivalence studies have been developed for biogenerics. The Bioequivalence Center has all the resources to provide services for conducting full-cycle therapeutic equivalence studies.