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The EAEU approved the Guidelines for the study of bioequivalence of liposomal drugs

By the decision of the Board of the Eurasian Economic Commission No. 111 on September 15, the Guidelines for the pharmacokinetic and clinical study of the bioequivalence of liposomal drugs (MP) for intravenous administration were approved. The document was published on the EAEU legal portal docs.eaeunion.org on September 18, the decision comes into force 6 months after the date of its official publication.

Application of this Guide will allow the developer (manufacturer) of liposomal medicinal products to obtain the necessary data on quality, data from preclinical and clinical studies to substantiate the registration of liposomal medicinal products developed as analogues of the reference liposomal medicinal product.

The document contains instructions on the following issues:

• submission of pharmaceutical data as part of the registration dossier of medicinal products required to confirm the comparability of the reproduced liposomal medicinal product to the reference liposomal medicinal product or to confirm the comparability of the modified liposomal medicinal product to the original liposomal medicinal product in order to substantiate the comparable safety and efficacy of such drugs;
• the need for preclinical and clinical studies and the circumstances allowing to refuse to conduct certain studies;
• design of relevant in vivo preclinical studies and the potential role of in vitro models.

The principles outlined in the Guide may also apply to new types of drugs, like liposomal and vesicular drugs, that may be in development (including routes of administration other than intravenous administration). Pharmaceutical preparations based on phospholipids, in which the release of the active substance from the phospholipid system does not occur, that is, in which such a system serves exclusively as a solvent for the active substance, do not belong to liposomal or liposomal drugs and are not considered in this guide.

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