The Siberian Scientific Medical Journal
№ 3 / 2018 / 16-29
DOI 10.15372/SSMJ20180303


Author Affiliations


The review presents materials on the scientific principles underlying the development, preclinical and clinical research, registration and control of the safety of biosimilar medicines produced using genetic engineering techniques. The number of biosimilars used in the clinic, defined as «biosimilars», is steadily increasing. The features of biotechnological preparations are presented, that requires a special approach to assessing the newly developed preparation evidence of similarity with the original (reference) preparation. To ensure the effectiveness and safety of their use, the procedure for registration of such medicines is determined by the regulatory framework governing the requirements for proof of similarity with previously approved biological medicinal products. The data concerning the differences in the nature and scope of studies at the stages of quality assessment, preclinical and clinical development of biosimilar and original drugs are performed. The issues related to extrapolation of clinical trial results and the issues of medicines interchangeability are reported. The modern information on international experience of biosimilar medicines registration, scientific achievements and regulatory requirements concerning evidence of similarity in assessing the quality, effectiveness and safety of biosimilar biotechnological medicines («biosimilars») has been reported.

Key words

biosimilars, biotechnological medicines, quality control, preclinical studies, clinical studies, extra­polation, safety, interchangeability
About Authors (Correspondence):

Avdeeva Zh.I. – doctor of medical sciences, professor, chief expert of office for allergen expertise, cytokines and other immunomodulators of center for examination and control of medical immunobiological preparations

Full Text

Received: 27/06/2018
Accepted: 27/06/2018