Recently, an article was published on our website on such groups of medicinal products as reference, reproduced and bioanalogue drugs, where the key difference, namely the absence of full clinical trials, between reproduced and reference drugs from the registration point of view was discussed. (read more about this in the article “Reference, generic and biosimilar drugs.”). This publication will be devoted to another category of drugs — interchangeable drugs.
- What is an interchangeable drug?
Interchangeable is a medicinal product with proven therapeutic equivalence or bioequivalence with respect to a reference medicinal product having equivalent quality composition and quantity of active substances, composition of excipients, dosage form and method of administration.
Information on the interchangeable drug can be found in the state register of medicines (https://grls.rosminzdrav.ru/Default.aspx, item 12 of the registration certificate for reference drugs). For example, for the reference drug Pentalgin® -ICN, the interchangeable drug is Santoperalgin (LSR-002670/08).
If we compare the definition of generic (=reproduced) and interchangeable drugs, we can conclude that the interchangeable LP is a broader concept. A generic drug is a drug that has the same qualitative composition and quantity of active substances in the same dosage form (DF) as the reference drug. An interchangeable drug implies a change in the composition and dosage form provided that the interchangeability parameters are maintained.
- What does that mean?
The interchangeability of drug is confirmed in the course of registration (examination of the ratio of expected benefit to the possible risk of using LP) of the interchangeable drug on the basis of the following parameters (Art. 27.1 FZ 61):
- Equivalence of the qualitative and quantitative characteristics of pharmaceutical substances studied in the bioequivalence (BE) or therapeutic equivalence (TE) study
- Equivalence of the dosage form (it can be different DF having the same method of administration and method of application having comparable pharmacokinetic characteristics and pharmacological action and also ensuring the achievement of the necessary clinical effect)
- Equivalence or comparability of the composition of the excipients of the DF (differences in the composition of the excipients of the drug are not an obstacle to their interchangeability if in the study of the BE/TE for the drug absence of clinically significant differences in pharmacokinetics and/or safety and efficacy of LP is proved). At the same time, differences in the composition of excipients should not lead to the risk of serious undesirable reactions in certain groups of patients or increase the frequency of their occurrence);
- Identity of the method of introduction and application;
- Absence of clinically significant differences during the study of BE/TE of a drug;
- Compliance of the manufacturer of drugs with GMP requirements;
Based on the results of the examination, the conclusion with the appropriate appendix is drawn up, which provides the conclusion for each of the parameters, as well as its justification.
- Федеральный закон от 12.04.2010 N 61-ФЗ (ред. от 27.12.2018) “Об обращении лекарственных средств”
- Приказ Минздрава России от 24.08.2017 N 558н “Об утверждении Правил проведения экспертизы лекарственных средств для медицинского применения и особенности экспертизы отдельных видов лекарственных препаратов для медицинского применения (референтных лекарственных препаратов, воспроизведенных лекарственных препаратов, биологических лекарственных препаратов, биоаналоговых (биоподобных) лекарственных препаратов (биоаналогов), гомеопатических лекарственных препаратов, лекарственных растительных препаратов, комбинаций лекарственных препаратов), форм заключений комиссии экспертов”
- Постановление Правительства РФ от 28.10.2015 N 1154 “О порядке определения взаимозаменяемости лекарственных препаратов для медицинского применения”
©Beawire – June 2019.