Similar biological medicinal products, containing monoclonal antibodies - application in real clinical practice

Similar biological medicinal products, containing monoclonal antibodies - application in real clinical practice

Oral presentation

Simeon Georgiev1, Iva Parvova2, Еmil Hristov1, Sava Ognyanov1
1Faculty of Chemistry and Pharmacy, SU ”St.Kliment Ohridsky” 2Clinic of Rheumatology, Department of Internal Medicine, Medical University of Sofia

Biological medicinal products containing monoclonal antibodies penetrate extensively in clinical practice in areas such as rheumatology, oncology, gastroenterology and others. Biological medicinal products are more difficult to describe in comparison with chemically synthesized (eg, obtained by recombinant DNA technology, blood or plasma products, immunological products, gene and cell therapy, etc.). The reasonable question are - these products can be copied, how, in what order and how they are called? We can found the answers in so called “The concept of similar biological medicinal product” which is applicable to any biological product. Features such as three-dimensional structure, amount of acid- base variants or post-translational modifications such as glycosylation profile can be significantly different by changes initially considered as a minor in the manufacturing process. Therefore, the profile of efficacy/safety of these products is highly dependent on the quality of the manufacturing process and product quality characteristics. Pharmaceutical form, the strength, posology and method of administration of biosimilar medicinal products must be exactly the same with the reference biological product. The introduction into the real clinical practice of "Similar" biological medicinal products raises a number of additional questions - on the one hand, their inclusion in the therapeutic algorithms, the possibilities for substitutability (swithching) and interchangeability, the occurrence of adverse drug reactions, the individual variability, etc., and from the other hand - pharmacoeconomic aspects of this type of therapies.