PB006: A Natalizumab Biosimilar

• Published in: Clinical drug investigation Vol. 44; no. 5; pp. 367 - 370
• Main Author: Shirley, Matt
• Format: Journal Article
• Language: English
• Published: Cham Springer International Publishing 01.05.2024; Springer Nature B.V
• Subjects: Adis Biosimilar Brief; Antibodies; Biological products; Biosimilar Pharmaceuticals - adverse effects; Biosimilar Pharmaceuticals - pharmacokinetics; Biosimilar Pharmaceuticals - therapeutic use; Cell adhesion & migration; Drug dosages; Humans; Internal Medicine; Magnetic resonance imaging; Medicine; Medicine & Public Health; Monoclonal antibodies; Multiple sclerosis; Multiple Sclerosis, Relapsing-Remitting - drug therapy; Natalizumab - adverse effects; Natalizumab - therapeutic use; Pharmacodynamics; Pharmacokinetics; Pharmacology/Toxicology; Pharmacotherapy
• ISSN: 1173-2563; 1179-1918; 1179-1918
• DOI: 10.1007/s40261-024-01360-4

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.