Marketing research of biological drugs used in rheumatoid arthritis

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Abstract

Introduction. Advances in the treatment of rheumatoid arthritis (RA) are associated with the rational use of biological disease-modifying antirheumatic drugs (bDMARDs). This group of drugs is represented by a wide range of humanized (tocilizumab, olokizumab) and human (adalimumab, golimumab, sarilumab, etc.) monoclonal antibodies, pegylated antibody fragments (certolizumab pegol), hybrid fusion antibodies (abatacept) and recombinant forms of the human IL-1 receptor antagonist (anakinra).

Objective. Marketing analysis of the range of bDMARDs recommended for the treatment of rheumatoid arthritis by the current version of the clinical guidelines “Rheumatoid Arthritis”, 2024 for the subsequent comprehensive assessment of available healthcare technologies.

Material and methods. Analysis and classification of information obtained from the records of the state register of medicines based on the following criteria: 1) availability of approved biosimilars; 2) available dosage forms; 3) available routes of administration; 4) possibility of self-administration of the drug by the patient; 5) localization of production.

Results. As of the beginning of 2025, 25 trade names of bDMARDs were registered in Russia. The drugs are registered in the dosage forms of “lyophilizate”, “concentrate for solution preparation”, “solution for subcutaneous administration” and are available for subcutaneous and intravenous administration. For 2019–2024, an expansion of the range of bDMARDs for subcutaneous administration was revealed – out of 8 new drugs, six drugs are produced in the dosage form of "solution for subcutaneous administration". A trend towards expansion of the biosimilar drug market was identified – the first biosimilar of bDMARDs was registered in 2014 and as of the beginning of 2025, the share of biosimilars already amounts to 44% (11 drugs out of 25 bDMARDs).

Conclusion. The study systematized the basic information about biologic drugs, identified a trend of expansion of the biosimilar drug market. In recent years, the development of dosage forms for subcutaneous administration has been actively underway, as the most convenient for the patient and economical for the healthcare system as a whole.

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About the authors

Larisa I. Lavrenteva

Federal State Budgetary Educational Institution of Higher Education “Yaroslavl State Medical University” of the Ministry of Healthcare of the Russian Federation

Author for correspondence.
Email: lavl2004@mail.ru
ORCID iD: 0000-0002-4381-9513
SPIN-code: 4531-7974

Doctor of Pharmaceutical Sciences, Professor, Head of the Department of Pharmacy Management and Economics, Director of the Institute of Pharmacy

Russian Federation, 150000, Yaroslavl, Revolutsionnaya street, 5

Anton V. Zakharov

Federal State Budgetary Educational Institution of Higher Education “Yaroslavl State Medical University” of the Ministry of Healthcare of the Russian Federation

Email: zzakharov96@gmail.com
ORCID iD: 0009-0004-7509-7326
SPIN-code: 4201-0138

postgraduate student of the Department of Pharmacy Management and Economics

Russian Federation, 150000, Yaroslavl, Revolutsionnaya street, 5

Andrey A. Baranov

Federal State Budgetary Educational Institution of Higher Education “Yaroslavl State Medical University” of the Ministry of Healthcare of the Russian Federation

Email: bara_aa@mail.ru
ORCID iD: 0000-0001-7847-1679
SPIN-code: 4497-7008

Doctor of Medical Sciences, Professor, Head of the Department of Outpatient Therapy, Clinical, Laboratory Diagnostics and Medical Biochemistry

Russian Federation, 150000, Yaroslavl, Revolutsionnaya street, 5

Anna V. Smirnova

Federal State Budgetary Educational Institution of Higher Education “Yaroslavl State Medical University” of the Ministry of Healthcare of the Russian Federation

Email: smirnova@ysmu.ru
ORCID iD: 0000-0003-0752-3632
SPIN-code: 2983-5528

Candidate of Pharmaceutical Sciences, Head of the Course of Pharmaceutical and Toxicological Chemistry, Department of Chemistry with the Course of Pharmaceutical and Toxicological Chemistry

Russian Federation, 150000, Yaroslavl, Revolutsionnaya street, 5

References

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Supplementary files

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2. Fig. 1. The structure of the pharmaceutical market of bDMARDs, based on the originality of the drug [12]

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3. Fig. 2. Number of registered dosage forms of bDMARDs for the period 2019 – early 2025

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4. Fig. 3. The structure of localization of production sites of the bDMARDs, in circulation on the territory of Russia at the beginning of 2025 [10]

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