Regulatory approaches to evaluation of biosimilars for treatment of rheumatic diseases

QR Code

Regulatory approaches to evaluation of biosimilars for treatment of rheumatic diseases

The article discusses the design of development programmes for biosimilars used to treat patients with rheumatic diseases. It analyses the most popular definitions of biosimilars that are used in Russia and abroad, as well as regulatory approaches to establishing biosimilarity. The authors describe...

Full description

Saved in:

Bibliographic Details
Main Authors:	D. V. Goryachev, M. Yu. Telnykh, N. D. Bunyatyan
Format:	Article
Language:	Russian
Published:	Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’) 2018-02-01
Series:	Регуляторные исследования и экспертиза лекарственных средств
Subjects:	биоаналогичные препараты биоаналоги референтные препараты регуляторные подходы ревматические заболевания biosimilar products biosimilars reference products regulatory approaches rheumatic diseases
Online Access:	https://www.vedomostincesmp.ru/jour/article/view/135
Tags:	Add Tag No Tags, Be the first to tag this record!

Similar Items

Biosimilars - advantages and prospects
by: A. A. Lidzhiyeva, et al.
Published: (2018-02-01)

The safety of biological preparations. Part 2. Safety issues of biosimilars
by: A. A. Soldatov, et al.
Published: (2018-02-01)

First available biosimilar monoclonal antibodies
by: Zh. I. Avdeeva, et al.
Published: (2018-02-01)

BIOSIMILARS, PRODUCED USING THE RECOMBINANT DNA TECHNOLOGY
by: Z. I. Avdeeva, et al.
Published: (2019-02-01)

Authorisation of Non-Innovator Biotherapeutic (Biosimilar) Products in the USA
by: A. A. Soldatov, et al.
Published: (2019-03-01)

Biologics and biosimilars in musculoskeletal diseases: addressing regulatory inconsistencies and clinical uncertainty
by: Lauren N. McGrath, et al.
Published: (2025-07-01)

Modern biological/biotechnological medicinal products. Topical issues and prospects for development
by: Yu. V. Olefir, et al.
Published: (2018-02-01)

Patent and Regulatory Landscape of Biosimilars in the United States and Europe: Implications for Advancing the Domestic Biosimilar Industry with a Focus on Anti-TNF-α Biopharmaceuticals
by: Tae-Kwon Kim, et al.
Published: (2025-06-01)

ANALYSIS OF THE RANGE OF MEDICINES USED TO TREAT COMMON OCCUPATIONAL DISEASES OF COAL INDUSTRY WORKERS
by: Андрей Георгиевич Петров, et al.
Published: (2020-12-01)

NSAID-INDUCED GASTROPATHIES IN CHILDREN WITH RHEUMATIC DISEASES: DIAGNOSTICS AND TREATMENT
by: P I Nikishina, et al.
Published: (2000-02-01)

Periodontal pathology in rheumatic diseases: a prospective direction of interdisciplinary studies
Published: (2020-04-01)

BIOSIMILARS IN RHEUMATOLOGY
by: E. L. Nasonov
Published: (2017-01-01)

Pharmacoeconomic rationale for switching patients with rheumatic diseases from original biologic disease-modifying antirheumatic drugs to biosimilars in context of the Russian healthcare system
by: A. Yu Kulikov, et al.
Published: (2022-06-01)

Erelzi<sup>®</sup> – biosimilar of etanercept in the treatment of rheumatic diseases and psoriasis (Resolution of the Expert Panel)
by: V. I. Mazurov, et al.
Published: (2021-08-01)

MODERN PROBLEMS OF RATIONAL USE OF NONSTEROIDAL ANTI-INFLAMMATORY DRUGS IN THE TREATMENT OF OCCUPATIONAL DISEASES OF COAL INDUSTRY WORKERS
by: Андрей Георгиевич Петров, et al.
Published: (2019-02-01)

Lo que debe saber el dermatólogo sobre los medicamentos biológicos y los biosimilares
by: Gloria Sanclemente
Published: (2019-03-01)

Approaches to resolve practical challenges in the context of assessing the price of biosimilar products
by: A. H.-M. Valeeva, et al.
Published: (2025-01-01)

Real-World Evidence Assessing the Safety of Administering Intravenous Rituximab Biosimilar in the First Cycle and Subcutaneous Rituximab in Subsequent Cycles in B-Cell Lymphoma Patients
by: Tamather Almandeel, et al.
Published: (2025-06-01)

Options to optimize the access to biosimilars: analysis and solutions
by: O. V. Kirsanova, et al.
Published: (2018-05-01)

Optimizing development of anti-TNFα biosimilars based on 10 years’ experience
by: Cecil Nick
Published: (2025-02-01)

International standards for monoclonal antibodies for assessing the biological activity of medicines: A status update
by: L. A. Gayderova, et al.
Published: (2023-12-01)

The results of investigating the efficacy and safety of non-medical switching from the original rituximab to its biosimilar in rheumatoid arthritis patients (AMBIRA study)
by: M. A. Korolev, et al.
Published: (2021-01-01)

A phase I, randomized, double-blind, parallel, single-dose pharmacokinetic study to evaluate the biosimilarity of KM118 (proposed pertuzumab biosimilar) with reference pertuzumab (Perjeta®) in healthy male subjects
by: Yan Li, et al.
Published: (2025-12-01)

Actualización en biosimilares: una reflexión sobre la reglamentación en Colombia de los medicamentos biológicos y biosimilares
by: Juan Raul Castro-Ayarza, et al.
Published: (2015-01-01)

Comparison of the efficacy and safety of the original rituximab and its biosimilar in routine clinical practice
by: D. A. Kusevich, et al.
Published: (2022-06-01)

Principles of rehabilitation of rheumatic patietts
by: V P Pavlov, et al.
Published: (2005-04-01)

Selecting the best-value biosimilar in emerging countries
by: Gilberto Castañeda-Hernández
Published: (2024-09-01)

Dynamics of prices and consumption of anticancer drugs in Russia after their generics and biosimilars became available
by: F. V. Gorkavenko, et al.
Published: (2019-07-01)

Clinical Comparison of Renogen, a Biosimilar Epoetin-a, with the Originator, Eprex, in Chronic Kidney Disease Anemia in Indonesia: A Preliminary Study
by: Ni Made Hustrini, et al.
Published: (2019-11-01)

Clinical Comparison of Renogen, a Biosimilar Epoetin-a, with the Originator, Eprex, in Chronic Kidney Disease Anemia in Indonesia: A Preliminary Study
by: Ni Made Hustrini, et al.
Published: (2019-11-01)

INTERNATIONAL APPROACHES TO THE GOVERNMENT PRICE CONTROL OVER GENERICS AND BIOSIMILARS: A REVIEW
by: D. G. Tolkacheva, et al.
Published: (2018-02-01)

INTERNATIONAL APPROACHES TO THE GOVERNMENT PRICE CONTROL OVER GENERICS AND BIOSIMILARS: A REVIEW
by: D. G. Tolkacheva, et al.
Published: (2018-02-01)

Comparative Studies of Biosimilar Medicinal Products
by: O. B. Talibov
Published: (2019-06-01)

Efficacy and safety of adalimumab biosimilar GP2017 in a 24-month treatment period for plaque psoriasis: real-life experience from Emilia-Romagna centers, Italy
by: Marco May Lee, et al.
Published: (2025-07-01)

Role of biosimilars in neutropenia prevention in cancer patients
by: V. V. Ptushkin
Published: (2015-01-01)

A Double-blind Randomized Comparative Phase I Study to Assess Biosimilarity and Immunogenicity of "Trastuzumab" (LLC "Mabscale", Russia) and Herceptin® (F. Hoffmann-La Roche Ltd., Switzerland) in Healthy Volunteers
by: M. A. Kolganova, et al.
Published: (2023-09-01)

Comparative efficacy and safety of adalimumab biosimilar (BCD-057) and innovator in patients with psoriasis vulgaris. Results of the BCD-057-2/CALYPSO phase III international, multicenter, randomized double-blind clinical trial
by: Т. V. Korotaeva, et al.
Published: (2018-12-01)

Dynamics of lymphocyte subpopulations, CD4+CD25+CD127- T regulatory cells in patients with rheumatoid arthritis during therapy with the rituximab biosimilar Acellbia
by: A. S. Avdeeva, et al.
Published: (2020-05-01)

Biosimilars - drugs of the future
by: E. A. Eltcova, et al.
Published: (2014-04-01)

Reorganization of public procurement of biosimilars and its economic effect on the monoclonal antibody market in Russia
by: A. Yu. Efremov, et al.
Published: (2025-05-01)