Comparative Immunogenicity of Biosimilar Natalizumab
Overview
Biosimilar natalizumab (biosim-NTZ) is the first biosimilar version of the original natalizumab (ref-NTZ) used to treat relapsing forms of multiple sclerosis (MS). This study aimed to confirm that biosim-NTZ has a similar immunogenicity profile to ref-NTZ.
Study Methods
Two key clinical studies were conducted:
- Efficacy and Safety Study: 264 patients with relapsing-remitting MS received monthly infusions of either biosim-NTZ or EU-ref-NTZ for 48 weeks. The main focus was on the first 24 weeks.
- Pharmacokinetic/Pharmacodynamic Study: 450 healthy subjects received a single dose of biosim-NTZ, US-ref-NTZ, or EU-ref-NTZ, followed by an 85-day monitoring period.
Advanced bioanalytical methods were used to detect anti-drug antibodies (ADA) and neutralizing antibodies (NAb) over time.
Key Findings
The results showed:
- Similar rates of overall ADA (79.4% for biosim-NTZ vs 73.7% for EU-ref-NTZ) and NAb (68.7% vs 66.2%) at 24 weeks.
- ADA levels remained consistent throughout the study.
- Switching from EU-ref-NTZ to biosim-NTZ did not affect ADA/NAb levels or clinical outcomes.
- The single-dose study also showed matching ADA rates and profiles across treatment groups.
Conclusion
The immunogenicity profile of biosim-NTZ is confirmed to be similar to that of ref-NTZ in both healthy subjects and MS patients, using highly sensitive testing methods.
Value of Clinical Trials
Clinical trials are essential for developing safe and effective treatments. To make these benefits accessible in everyday practice, we offer DocSym, an AI-driven platform that consolidates ICD-11 standards, clinical protocols, and research into one easy-to-use resource for healthcare providers.
Streamlining Healthcare Operations
In today’s healthcare landscape, efficiency is vital. Our mobile applications assist with scheduling, treatment monitoring, and telemedicine, simplifying patient care management and expanding digital services.
Improving Patient Outcomes
By leveraging AI, clinics can optimize workflows, enhance patient outcomes, and reduce reliance on paper processes. Discover how we can assist you at aidevmd.com.
