Comparative Study of Biosimilar Natalizumab and Reference Medicine
Author Information
Author(s): Chamberlain Paul, Hemmer Bernhard, Höfler Josef, Wessels Hendrik, von Richter Oliver, Hornuss Cyrill, Poetzl Johann, Roth Karsten
Primary Institution: Polpharma Biologics S.A.
Hypothesis
Does the biosimilar natalizumab have a matching immunogenicity profile compared to its reference medicine?
Conclusion
The immunogenicity profile of biosim-NTZ matches that of ref-NTZ in healthy subjects and patients with RRMS.
Supporting Evidence
- Biosim-NTZ and EU-ref-NTZ showed similar incidences of overall ADA and NAb.
- Switching treatment from EU-ref-NTZ to biosim-NTZ had no impact on ADA/NAb or clinical responses.
- Both studies used highly sensitive bioanalytical assays to assess immunogenicity.
Takeaway
This study shows that a new version of a medicine called biosimilar natalizumab works just as well as the original version without causing more problems.
Methodology
Two pivotal clinical studies were conducted: one comparing efficacy and safety in patients with RRMS and another assessing pharmacokinetics in healthy subjects.
Potential Biases
Potential bias in self-reported adverse events and the observational nature of some data.
Limitations
The study may not account for long-term effects beyond the 48-week treatment period.
Participant Demographics
Patients with relapsing-remitting MS and healthy subjects, mean ages approximately 36 and 31 years respectively.
Statistical Information
P-Value
p<0.05
Confidence Interval
[72.5, 86.3]
Statistical Significance
p<0.05
Digital Object Identifier (DOI)
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