First biosimilar monoclonal antibody for MS shown to be safe, effective in phase 3 trial
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PB006, the first biosimilar for natalizumab, showed comparable safety, efficacy and immunogenicity to the reference monoclonal antibody therapy in patients with relapsing-remitting MS, researchers wrote in JAMA Neurology.
“PB006 is a biosimilar natalizumab (biosim-NTZ) and was developed by Polpharma Biologics SA as a proposed biosimilar to the reference natalizumab (ref-NTZ) in accordance with FDA and [European Medicines Agency] guidelines, which require biosimilars to match the reference medicine in analytical comparability, bioequivalence, safety, efficacy and immunogenicity, confirming no clinically relevant differences in performance across approved indications,” Bernhard Hemmer, MD, of the department of neurology at the Technical University of Munich, and colleagues wrote.
Hemmer and colleagues sought to evaluate matching efficacy, safety and immunogenicity between biosim-NTZ and ref-NTZ in patients with relapsing-remitting MS in a phase 3, parallel-group, randomized, active-controlled study, which was conducted in 48 centers across seven countries.
Researchers screened 531 patients with relapsing-remitting MS, aged 18 to 60 years, and excluded 266 patients before randomization.
Eligible participants received IV infusions of 300 mg biosim-NTZ or 300 mg ref-NTZ every 4 weeks from baseline to week 44. At week 24, researchers rerandomized the ref-NTZ group, and 30 patients were switched to receive the biosimilar for the rest of the study.
A total of 264 participants (mean age, 36.7 years; 61.4% women) received treatment with biosim-NTZ (n = 131) or ref-NTZ (n = 133). At week 24, the model-based mean difference in cumulative number of new active lesions between biosim-NTZ and ref-NTZ treatment groups was 0.17 (least square means: biosim-NTZ = 0.34; ref-NTZ = 0.45; 95% CI, –0.61 to 0.94).
The researchers reported no significant differences between the two cohorts across secondary efficacy endpoints, as well as safety, tolerability or immunogenicity assessments.
“The clinical efficacy, safety and immunogenicity of the proposed biosimilar natalizumab matched the reference natalizumab in the tested setting, with no clinically relevant differences observed,” Hemmer and colleagues wrote. “The results from this phase 3 trial support biosimilarity of proposed biosimilar natalizumab PB006 to its reference medicine in [relapsing-remitting MS].”