Efficiency and safety of generics (literature review)

In recent decades, the issue of using generics has become significant in the markets for pharmaceuticals, pesticides, and other industrial products. This review examines current approaches to assessing the effectiveness and safety of generics including pharmaceuticals and pesticides. The review is based on data from domestic and foreign literature, as well as online resources. Information was searched from the OECD, Scopus, Medline, and RSCI databases. The review presents and discusses the regulatory documents governing the assessment of the effectiveness and safety of generics. For generic drugs, pharmaceutical, biological, and therapeutic equivalence is evaluated. Technical-grade active ingredients of generic pesticides are not subjected to a full cycle of studies if their equivalence to the original active substance has been demonstrated. In such cases, the assessment includes the manufacturing process of the generic pesticide, the minimum content of the active substance, and the maximum allowable levels of impurities, supported by the analysis of at least five production batches. Additionally, an in silico hazard assessment of impurities is conducted. The genotoxicity of the technical-grade product and/or its impurities is also evaluated, and if necessary, toxicological, ecotoxicological, or other relevant data on the technical-grade product and/or its impurities are considered. The effectiveness of pesticides is assessed under the real-world (field) trials.

Contribution:
Ilyushina N.A. – concept and design of the study, processing and analysis of material, writing the text;
Egorova O.V. – processing and analysis of material;
Revazova Yu.A. – writing the text; processing and analysis of material.
All authors are responsible for the integrity of all parts of the manuscript and approval of the manuscript final version.

Conflict of interest. The authors declare no conflict of interest.

Funding. The study is a part of the state assignment (registration № 125012700793-3).

Received: April 2, 2025 / Accepted: July 14, 2025 / Published: September 25, 2025

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