Natalizumab – the first biosimilar drug for multiple sclerosis and its importance in clinical practice Review article

Abstract

Multiple sclerosis remains one of the most common chronic inflammatory diseases of the central nervous system, and contemporary therapeutic strategies increasingly rely on the early initiation of high-efficacy therapies (HETs). Among these, natalizumab, a monoclonal antibody with well-established efficacy in the treatment of highly active multiple sclerosis, occupies a prominent position.

The aim of this review is to present the role of biosimilars in neurology, with particular emphasis on biosimilar natalizumab (Tyruko®, PB006) as the first biosimilar high-efficacy therapy approved for the treatment of multiple sclerosis. The article discusses the regulatory framework governing the approval of biosimilars, the development program of PB006, and the evidence supporting its analytical, pharmacokinetic, pharmacodynamic, clinical, and immunological equivalence to the reference product.

Current evidence regarding switching from reference natalizumab to its biosimilar is also reviewed, demonstrating the maintenance of efficacy, safety, and comparable immunogenicity. Particular attention is given to the potential role of biosimilar natalizumab in improving access to high-efficacy therapies through the optimization of public healthcare resources and enhanced healthcare system efficiency.

Furthermore, the article highlights the clinical relevance of the intravenous route of natalizumab administration with respect to predictable drug exposure, safety monitoring, and continuity of patient care. The introduction of biosimilar natalizumab may represent an important step toward the broader implementation of high-efficacy treatment strategies, enabling a greater number of patients to  benefit from effective therapy while maintaining high standards of efficacy and safety.