Methodological and regulatory aspects of pharmaceutical development of biological products
The aim of the work was to conduct an analysis of the current state and current trends in the approval of drugs, as well as some aspects of the methodology for their development based on biological molecules and registration.Materials and methods. The material for the analysis was taken from the abs...
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| Format: | Article |
| Language: | Russian |
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Volgograd State Medical University, Pyatigorsk Medical and Pharmaceutical Institute
2024-01-01
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| Series: | Фармация и фармакология (Пятигорск) |
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| Online Access: | https://www.pharmpharm.ru/jour/article/view/1392 |
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| author | D. V. Kurkin E. I. Morkovin D. A. Bakulin A. V. Zaborovsky I. E. Makarenko R. V. Drai A. G. Solodovnikov V. I. Petrov K. N. Koryanova N. A. Lycheva S. A. Voskresensky A. V. Strygin Yu. A. Kolosov Yu. V. Gorbunova O. V. Ivanova |
| author_facet | D. V. Kurkin E. I. Morkovin D. A. Bakulin A. V. Zaborovsky I. E. Makarenko R. V. Drai A. G. Solodovnikov V. I. Petrov K. N. Koryanova N. A. Lycheva S. A. Voskresensky A. V. Strygin Yu. A. Kolosov Yu. V. Gorbunova O. V. Ivanova |
| author_sort | D. V. Kurkin |
| collection | DOAJ |
| description | The aim of the work was to conduct an analysis of the current state and current trends in the approval of drugs, as well as some aspects of the methodology for their development based on biological molecules and registration.Materials and methods. The material for the analysis was taken from the abstract databases of PubMed, Google Scholar and e-library.ru. The search was carried out using publications for the period from 2008 to 2023, the keywords were as follows: “biologicals”, “new drug approval”, “drug authorization”, “drug development”, “biosimilar”, taking into account various spellings.Results. Over the past 15 years, scientists have been observing revolutionary trends and processes in the field of the drug development, especially biopharmaceuticals. Significant advances have been made in gene, immune and cell therapies, resulting in the approval of such drugs more than doubling over the past ten years. The development of biological drugs includes the identification and testing of molecular targets and requires a deep understanding of the structure and functioning of the polypeptides involved in the development of the effect. The features of these active pharmaceutical substances are a high molecular weight, a complex three-dimensional structure and a high immunogenic potential. Preclinical and clinical studies of biologics have unique challenges. Selecting appropriate animal species, understanding the immunogenicity, and assessing pharmacodynamics and toxicological properties require a multilevel, detailed approach. The article discusses the regulatory framework under which these drugs are registered, summarizing the guidelines provided by international organizations such as the International Council for Harmonization and various national agencies.Conclusion. The analysis highlights the current advances and prospects in the development of biologics, highlighting their key role in future transformations in the treatment of rare diseases and oncology, approaching the era of personalized medicine. Monitoring the development directions and technological approaches, as well as the commitment to global methodological and regulatory aspects can become a catalyst in the development of the Russian pharmacology. |
| format | Article |
| id | doaj-art-2dc8114950e748bbbd40243f3b14fe6b |
| institution | DOAJ |
| issn | 2307-9266 2413-2241 |
| language | Russian |
| publishDate | 2024-01-01 |
| publisher | Volgograd State Medical University, Pyatigorsk Medical and Pharmaceutical Institute |
| record_format | Article |
| series | Фармация и фармакология (Пятигорск) |
| spelling | doaj-art-2dc8114950e748bbbd40243f3b14fe6b2025-08-20T02:55:58ZrusVolgograd State Medical University, Pyatigorsk Medical and Pharmaceutical InstituteФармация и фармакология (Пятигорск)2307-92662413-22412024-01-0111538439810.19163/2307-9266-2023-11-5-384-398493Methodological and regulatory aspects of pharmaceutical development of biological productsD. V. Kurkin0E. I. Morkovin1D. A. Bakulin2A. V. Zaborovsky3I. E. Makarenko4R. V. Drai5A. G. Solodovnikov6V. I. Petrov7K. N. Koryanova8N. A. Lycheva9S. A. Voskresensky10A. V. Strygin11Yu. A. Kolosov12Yu. V. Gorbunova13O. V. Ivanova141. Russian University of Medicine. 2. Volgograd State Medical University.1. Volgograd State Medical University. 2. Limited Liability Company “Statandocs”.Russian University of MedicineRussian University of Medicine1. Russian University of Medicine. 2. Closed Joint-Stock Company “Pharm-Holding”Closed Joint-Stock Company “Pharm-Holding”Limited Liability Company “Statandocs”Volgograd State Medical UniversityPyatigorsk Medical and Pharmaceutical Institute – branch of Volgograd State Medical UniversityRussian University of MedicineVolgograd State Medical UniversityVolgograd State Medical UniversityRussian University of MedicineRussian University of MedicineRussian University of MedicineThe aim of the work was to conduct an analysis of the current state and current trends in the approval of drugs, as well as some aspects of the methodology for their development based on biological molecules and registration.Materials and methods. The material for the analysis was taken from the abstract databases of PubMed, Google Scholar and e-library.ru. The search was carried out using publications for the period from 2008 to 2023, the keywords were as follows: “biologicals”, “new drug approval”, “drug authorization”, “drug development”, “biosimilar”, taking into account various spellings.Results. Over the past 15 years, scientists have been observing revolutionary trends and processes in the field of the drug development, especially biopharmaceuticals. Significant advances have been made in gene, immune and cell therapies, resulting in the approval of such drugs more than doubling over the past ten years. The development of biological drugs includes the identification and testing of molecular targets and requires a deep understanding of the structure and functioning of the polypeptides involved in the development of the effect. The features of these active pharmaceutical substances are a high molecular weight, a complex three-dimensional structure and a high immunogenic potential. Preclinical and clinical studies of biologics have unique challenges. Selecting appropriate animal species, understanding the immunogenicity, and assessing pharmacodynamics and toxicological properties require a multilevel, detailed approach. The article discusses the regulatory framework under which these drugs are registered, summarizing the guidelines provided by international organizations such as the International Council for Harmonization and various national agencies.Conclusion. The analysis highlights the current advances and prospects in the development of biologics, highlighting their key role in future transformations in the treatment of rare diseases and oncology, approaching the era of personalized medicine. Monitoring the development directions and technological approaches, as well as the commitment to global methodological and regulatory aspects can become a catalyst in the development of the Russian pharmacology.https://www.pharmpharm.ru/jour/article/view/1392biologicsbiosimilarsbiomoleculesregulationdevelopment and registrationu.s. food and drug administration |
| spellingShingle | D. V. Kurkin E. I. Morkovin D. A. Bakulin A. V. Zaborovsky I. E. Makarenko R. V. Drai A. G. Solodovnikov V. I. Petrov K. N. Koryanova N. A. Lycheva S. A. Voskresensky A. V. Strygin Yu. A. Kolosov Yu. V. Gorbunova O. V. Ivanova Methodological and regulatory aspects of pharmaceutical development of biological products Фармация и фармакология (Пятигорск) biologics biosimilars biomolecules regulation development and registration u.s. food and drug administration |
| title | Methodological and regulatory aspects of pharmaceutical development of biological products |
| title_full | Methodological and regulatory aspects of pharmaceutical development of biological products |
| title_fullStr | Methodological and regulatory aspects of pharmaceutical development of biological products |
| title_full_unstemmed | Methodological and regulatory aspects of pharmaceutical development of biological products |
| title_short | Methodological and regulatory aspects of pharmaceutical development of biological products |
| title_sort | methodological and regulatory aspects of pharmaceutical development of biological products |
| topic | biologics biosimilars biomolecules regulation development and registration u.s. food and drug administration |
| url | https://www.pharmpharm.ru/jour/article/view/1392 |
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