Reproduced drugs: Benefit ratio/risk

E.A. USHKALOVA¹, S.K. ZYRYANOV^1,2, I.A. GOPIENKO^1
1Peoples’ Friendship University of Russia, Moscow;
²City Clinical Hospital No. 24 of the Moscow Department of Health, Moscow

Place of publication:
NEUROLOGY, NEUROPSYCHIATRY, PSYCHOSOMATICS. 2021;13(6)

Abstract:
This review discusses the interchangeability of medicinal products (MPs), approaches to registering original and generic MPs, and types of equivalence, as well as issues with generics in clinical practice. Results of pharmacoepidemiological studies, widely cited in recent years, indicate insufficient understanding of the impact of generic drugs on long-term outcomes of chronic diseases, including mortality. The long-term economic prospects for the use of generic MPs remain unclear. The main reasons for the differences between original and generic MPs include differences in the methods of synthesizing active substances, as well as in the composition of excipients and impurities. Comparative studies of the therapeutic equivalence of generics with the original and with each other are relatively rare and often suffer from methodological flaws, which does not guarantee comparable efficacy and safety of such MPs. Therefore, the automatic substitution of MPs containing the same active substance without the involvement of the treating physician should be avoided.

Key words: generics; bioequivalence; pharmaceutical equivalence; therapeutic equivalence; interchangeability.