Biosimilars in the treatment of rheumatic diseases: pro et contra

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Biologic agents are indicated for treatment of various rheumatic diseases, including rheumatoid arthritis, ankylosing spondilitis, psoriatic arthritis, systemic vasculitides, usually as a second line of therapy if standard disease modifying antirheumatic drugs are ineffective, contraindicated or poorly tolerated. High costs of biologic agents remain the main barrier for their wider use in clinical practice. Development of less expensive biosimilars of certain medications that are no longer protected by patent provides an opportunity to reduce the costs for treatment and to expand access of patients with rheumatic diseases to effective treatment. Unlike small molecules, biologic agents have much more complex structure that defines strict requirements for their development and approval. Therefore, biosimilarity to reference agent should be established both in preclinical and randomised controlled clinical studies. After approval of a biosimilar, it is necessary to continue gathering safety and efficacy data in a larger number of patients. The authors review the results of clinical trials of the Russian biosimilar rituximab, infliximab, and adalimumab that have been recently approved for the treatment of rheumatic diseases. Their efficacy and safety comparable to those of the reference biologic agents were established in the phase 3 randomized controlled clinical trials.

Key words

Biologic agents, biosimilars, rheumatic diseases