The review provides with the information, related to the development, research and registration of new biological preparations, including the issues of terminology and classification. It also highlights the issues of and prospects for genetically engineered drugs, specific aspects of comparative studies to prove the similarity of a biosimilar and the original (reference) medicine, clinical use and interchangeability of preparations, prospects for the development of biotechnological medicines, expert evaluation of the quality of biological/ biotechnological medicines, modern methods of immunotherapy of allergic diseases by recombinant medicines, as well as the issues of cell technology and tissue engineering. The review also describes the topics discussed at the 14th International Conference «High Medical Technologies of 21st Century» (October 24-31, 2015, Spain), related to fundamental and applied research, development and introduction of new technologies and modern medicines into clinical practice.

The use of the reduced scheme in preclinical and clinical studies of «biosimilars» requires special attention to the safety issues. During the process of the marketing authorization of biosimilars in 2013-2015 the countries with advanced regulatory and pharmacovigilance systems (USA, Canada and EU countries), the most contentious debates were provoked by the issues of extrapolation of the results of the research of a biosimilar infliximab (TNFα-specific monoclonal antibodies). EMA made the decision that the results of the efficacy and safety studies of infliximab, obtained in adult patients with rheumatoid disease, can be extrapolated to the indications for the treatment of inflammatory bowel disease (Crohn’s disease and ulcerative colitis in adults and in children). Several medical associations such as the Association of Gastroenterologists and the Association of Pediatricians believe that this extrapolation is not justified. Health Canada also made a conclusion that the extrapolation is not justified and did not approve the use of the mentioned preparation for the treatment of Crohn’s disease and ulcerative colitis. There is still an ongoing hot discussion on the issue of interchangeability of an original medicine and a biosimilar. Given that the safety of a biosimilar has been studied before obtaining marketing authorization not to the fullest extent, usually safety studies continue after obtaining marketing authorization for a few more years. If there is an interchange of medicines, then it is not possible to objectively evaluate the safety of a biosimilar. In the countries with poor regulatory and pharmacovigilance system not only «biosimilars» are in drug circulation system, but also other medicines registered under the reduced studies scheme, but not in full compliance with the principles of «biosimilarity». The quality of these medicines does not always meet the standards, as evidenced by numerous studies. WHO is concerned about the quality of the mentioned medicines and suggests to call them «non-innovators» and establish a separate group, and claimed that the sponsors were invited for a certain period of time to provide the evidence of the high quality of these medicines.

The present article submits the results of work on the isolation and study of biological properties of bacteriophages, active against Klebsiella, Echerichia, Proteus, Pseudomonas, Staphylococcus. It also shows the results of the study such as: lytic activity, the definition of the spectrum of lytic action, sensitivity to damaging environmental factors: pH, temperature, freeze drying. The data of molecular genetic studies are provided.

Into the cells of Escherichia coli (strain BL21(DE3)) two forms of the fusion protein Pseudomonas aeruginosa containing the full length outer membrane protein F (OprF) and nontoxic form of Exotoxin A (without 106 C-terminal amino acid residues) have been synthesized. Two recombinant genes were inserted into plasmid pET28 in different order: oprF-atox and atox-oprF. Only oprF-atox variant allowed to obtain the recombinant protein sufficient for purification by affinity chromatography on Ni-Sepharose. The recombinant fusion protein OprF-aTox showed a high specificity in interaction with the preparations of polyclonal immune rabbit serum to the recombinant OprF, the recombinant nontoxic form of Exotoxin A and the bacterial cells of P. aeruginosa. The purified recombinant fusion protein OprF-aTox after two immunizations protected the mice against toxigenic strain of P. aeruginosa (РА-103) being injected intraperitoneally. The index of efficiency of protective properties of OprF-aTox in the optimal dose (50 µg protein per mouse) was 3.5. This was more efficient than in cases when the recombinant OprF and the recombinant toxoid were injected separately. The indexes of efficiency of protective properties of OprF and the toxoid were 2.1 and 2.0.

The present article contains scientific data on the assessment of specific activity of therapeutic humanized monoclonal antibodies against IL-17 in rabbit model of antigen-induced arthritis. Pharmacokinetics and immunogenicity of anti-IL-17A preparation have been studied. The severity of rheumatoid arthritis progression has been assessed by the levels of joint damage, the levels of inflammatory markers and according to Menkin histological grade.

The article presents the results of studies on the safety and efficacy of long-acting drug for the treatment of multiple sclerosis on the basis of recombinant human interferon beta-1a «PEGylated interferon beta-1a Human» (PEG IFN beta-1a) in monkeys Macaca mulatta in subcutaneous and intramuscular injection. The following doses were used: the maximum tolerated dose - 3.0·10⁶ IU/kg, the intermediate dose - 1.5·10⁶ IU/kg and the minimum dose, which was equivalent to human therapeutic dose of unmodified interferon beta-1a - 0.3·10⁶ IU/kg. Quantify the parameters of pharmacodynamics of the PEG IFN beta-1a after single subcutaneous and intramuscular administration of increasing doses of different groups of monkeys. Evaluated the level and nature of the pathological changes of internal organs (visceral systems) of experimental animals caused by repeated subcutaneous and intramuscular injections of PEG IFN-beta 1a. Based on these studies the drug PEG IFN beta-1a in rhesus monkeys indicated that the drug is efficient (both in single subcutaneous and intramuscular administration) and does not have toxic effects (both in multiple subcutaneous and intramuscular administration) when using a therapeutic dose 0.3·10⁶ IU/kg.

Timely diagnosis of particularly dangerous infections caused by viruses Ebola and Lassa is crucial in organization of anti-epidemic measures in the case of important of the disease on the territory of the Republic of Belarus. The main method of rapid response at revealing hemorrhagic fevers Lassa and Ebola still is the method of indirect immunofluorescence. In this work the elaboration of the kit for detection of antibodies to exciters of extremely dangerous viral infection Lassa and Ebola by indirect immunofluorescence method is described.

The method for the assessment of biological activity of erythropoietin preparations in vitro on TF-1 sensitive cells culture has been developed. The special characteristics of measurements and calculations of the biological activity of erythropoietin with different levels of glycosylation in vivo and in vitro. Linear response ranges for cell lines to erythropoietin and its hyperglycosylated analogue differ and make (0.39-0.56 ng/ml) and (3.1-12.5 ng/ml), respectively. The results have shown the possibility of using cellular test for comparing and assaying the activity of erythropoietin analogues in standard international units of biological activity (IU) set for erythropoietin.