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Development and improvement of biotechnological drugs currently more relevant than ever. Drugs obtained by means of biotechnology, have a number of positive qualities. Biotechnology allows you to create such products, which are currently impossible to synthesize by chemical means, in addition, the production of drugs using biotechnology meets the standards of quality, efficacy and safety and, more importantly, economically. Biotech drugs are used for treatment of infectious, autoimmune, cancer, are used to prevent, thereby finding wide application in medicine.

Biotechnologie is a rapidly developing branch of modern science, which is increasingly used in various fields, especially in medicine. Increasingly developed and introduced into medical practice of new Biopharmaceuticals - medicines derived from modern biotechnology. The development of technology in the production of “similar” medicines is gaining momentum and leads to a reduction in the cost and availability of drugs. On biotech drugs now pinning major hopes on a more affordable means of combating the most dangerous non-communicable diseases of modernity, such as cancer, multiple sclerosis, Alzheimer’s disease, storage diseases, etc. In this review we will discuss what is the difference between the original medicinal substance from the generic, and what is the bioequivalent. To date, the biosimilars market is actively developing and has very good growth prospects. According to experts of the pharmaceutical industry in the coming years, the biologics will be at least 50% of all medicines.

Objectives: To investigate the occurrence of adverse events (AEs) in naïve patients receiving biotech drugs.Design: A prospective observational study.Setting: Onco-hematology, Hepato-gastroenterology, Rheumatology, Dermatology, and Neurology Units in Campania Region (Italy).Participants: 775 patients (53.81% female) with mean age 56.0 (SD 15.2). The mean follow-up/patient was 3.48 (95% confidence interval 3.13–3.84).Main outcome measures: We collected all AEs associated to biotech drugs, including serious infections and malignancies. Serious AEs were defined according to the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, clinical safety data management: definitions and standards for expedited reporting E2A guideline.Results: The majority of the study population was enrolled in Onco-hematology and Rheumatology Units and the most common diagnosis were hematological malignancies, followed by rheumatoid arthritis, colorectal cancer, breast cancer, and psoriatic arthritis. The most commonly prescribed biotech drugs were rituximab, bevacizumab, infliximab, trastuzumab, adalimumab, and cetuximab. Out of 775 patients, 320 experienced at least one AE. Most of patients experienced AEs to cetuximab therapy, rituximab and trastuzumab. Comparing female and male population, our findings highlighted a statistically significant difference in terms of AEs for adalimumab (35.90% vs. 7.41%, p < 0.001) and etanercept (27.59% vs. 10.00%, p = 0.023). Considering all biotech drugs, we observed a peak for all AEs occurrence at follow-up 91–180 days category. Bevacizumab, brentuximab, rituximab, trastuzumab and cetuximab were more commonly associated to serious adverse events; most of these were possibly related to biotech drugs, according to causality assessment. Three cases of serious infections occurred.Conclusions: The results of our study demonstrated that the majority of AEs were not serious and expected. Few cases of serious infections occurred, while no case of malignancy did. Overall, the safety profile of biotech drugs used in our population was similar to those observed in pivotal trials. Notwithstanding the positive results of our study, some safety concerns still remain unresolved. In order to collect more effectiveness and safety data on biotech drugs, the collection and analysis of real world data should be endorsed as well as the management of post-authorization studies.

Objectives: To investigate the occurrence of adverse events (AEs) in naïve patients receiving biotech drugs. Design: A prospective observational study. Setting: Onco-hematology, Hepato-gastroenterology, Rheumatology, Dermatology, and Neurology Units in Campania Region (Italy). Participants: 775 patients (53.81% female) with mean age 56.0 (SD 15.2). The mean follow-up/patient was 3.48 (95% confidence interval 3.13-3.84). Main outcome measures: We collected all AEs associated to biotech drugs, including serious infections and malignancies. Serious AEs were defined according to the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, clinical safety data management: definitions and standards for expedited reporting E2A guideline. Results: The majority of the study population was enrolled in Onco-hematology and Rheumatology Units and the most common diagnosis were hematological malignancies, followed by rheumatoid arthritis, colorectal cancer, breast cancer, and psoriatic arthritis. The most commonly prescribed biotech drugs were rituximab, bevacizumab, infliximab, trastuzumab, adalimumab, and cetuximab. Out of 775 patients, 320 experienced at least one AE. Most of patients experienced AEs to cetuximab therapy, rituximab and trastuzumab. Comparing female and male population, our findings highlighted a statistically significant difference in terms of AEs for adalimumab (35.90% vs. 7.41%, p < 0.001) and etanercept (27.59% vs. 10.00%, p = 0.023). Considering all biotech drugs, we observed a peak for all AEs occurrence at follow-up 91-180 days category. Bevacizumab, brentuximab, rituximab, trastuzumab and cetuximab were more commonly associated to serious adverse events; most of these were possibly related to biotech drugs, according to causality assessment. Three cases of serious infections occurred. Conclusions: The results of our study demonstrated that the majority of AEs were not serious and expected. Few cases of serious infections occurred, while no case of malignancy did. Overall, the safety profile of biotech drugs used in our population was similar to those observed in pivotal trials. Notwithstanding the positive results of our study, some safety concerns still remain unresolved. In order to collect more effectiveness and safety data on biotech drugs, the collection and analysis of real world data should be endorsed as well as the management of post-authorization studies [ABSTRACT FROM AUTHOR]

This contribution deals with recently developed technology to obtain the novel biotech probiotic drugs on the basis of pre-selected and characterized strains of lactobacilli and bifidobacteria, which have antibacterial action and high level of ability to balance the immune response in infectious and inflammatory diseases of bacterial, viral and fungal origin by induction of various cytokines. We created an experimental model for the study of immunomodulatory activity of probiotic strains of lactobacilli and bifidobacteria in vitro and in vivo. We esteblished that the probiotic strains Lactobacillus acidophilus IMV B-7279, L. casei IMV B-7280, Bifidobacterium animalis VKL and B. animalis VKB, as well as different compositions based on probiotic strains might be promising for creating high-effective immune biotics with antibacterial and immune modulatory effects for treatments of infectious-and inflammatory diseases, caused by pathogenic and opportunistic microorganisms. [ABSTRACT FROM AUTHOR]

This article reviews the European guidelines on drugs comparability that establish the methodology for verifying biosimilarity between the so-called biosimilar drugs and the reference biological medicinal product. Biosimilars are biological medicines similar but not identical to the original drugs and can be manufactured by any laboratory after the expiration of biotech drugs patent. The guidelines of the European Medicines Agency (EMA) and the International Conference on Harmonization (ICH) that must be considered in the development and approval of these drugs also are reviewed. It is shown that biosimilars cannot be considered as generic drugs, being necessary to conduct additional assays prior to obtain marketing authorization. [ABSTRACT FROM AUTHOR]