Abstract
PB006 (Tyruko®) is the first biosimilar of the reference monoclonal anti-α4-integrin antibody natalizumab. It is approved for use in the same indications for which reference natalizumab is approved, as a single disease-modifying therapy in adults with highly active relapsing-remitting multiple sclerosis (RRMS). PB006 has similar physicochemical and pharmacodynamic properties to those of reference natalizumab, and the pharmacokinetic similarity of the agents has been demonstrated in a study in healthy subjects. PB006 demonstrated clinical efficacy similar to that of reference natalizumab in patients with RRMS, and was generally well tolerated in this population. The tolerability, safety and immunogenicity profiles of PB006 were similar to those of reference natalizumab, and switching from reference natalizumab to PB006 appeared to have no impact on tolerability or immunogenicity. The role of reference natalizumab in the management of RRMS is well established and PB006 provides an effective biosimilar alternative for patients requiring natalizumab therapy.
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During the peer review process, the manufacturer of PB006 was offered an opportunity to review this article. Changes resulting from comments received were made on the basis of scientific and editorial merit. Matt Shirley is a salaried employee of Adis International Ltd/Springer Nature, and declares no relevant conflicts of interest. All authors contributed to this article and are responsible for its content.
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The manuscript was reviewed by: I.-A. Chirap-Mitulschi, Department of Medicine II, University of Medicine and Pharmacy "Grigore T. Popa", Iaşi, Romania; F. Ladeira, Department of Neurology, Centro Hospitalar Universitário Lisboa Central, Lisbon, Portugal; D. Papadopoulos, School of Medicine, European University Cyprus, Nicosia, Cyprus; T. G. Schreiner, Faculty of Medicine, University of Medicine and Pharmacy "Grigore T. Popa", Iaşi, Romania.
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Shirley, M. PB006: A Natalizumab Biosimilar. Clin Drug Investig 44, 367–370 (2024). https://doi.org/10.1007/s40261-024-01360-4
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DOI: https://doi.org/10.1007/s40261-024-01360-4