Proposed biosimilar natalizumab (biosim-NTZ) PB006 is reference natalizumab (ref-NTZ) in a phase 3 clinical trial comparing the efficacy of different biosimilars in patients with relapsing-remitting multiple sclerosis (RRMS) were found to be consistent with the efficacy, safety, and immunogenicity of
The emergence of biosimilar drugs may enable affordable treatments for multiple sclerosis (MS) without compromising efficacy, according to research articles. Investigational natalizumab is the first biosimilar monoclonal antibody therapy developed for the treatment of multiple sclerosis.
“PB006 is a biosimilar natalizumab (biosim-NTZ) and is a proposed biosimilar of reference natalizumab (ref-NTZ) according to the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) guidelines Polpharma Biologics Developed by SA, which requires biosimilars to be consistent with the reference drug in analytical comparability, bioequivalence, safety, efficacy, and immunogenicity, and approved We confirm that there are no clinically relevant differences in performance across all indications,” the researchers wrote.
Phase 3 Clinical Trial Intervention
Between October 2019 and March 2021, Bernard Hemmer, MD, Department of Neurology, Technical University of Munich, Klinikum rechts der Isar, Munich & Munich Cluster for Systems Neurology (SyNergy) and the investigator were randomized. Phase 3 parallel groups were conducted. , an active-controlled Antelope clinical trial in 48 treatment centers in 7 countries. The patient’s final follow-up will be on him in August 2021.
After screening 531 relapsing-remitting multiple sclerosis patients aged 18 to 60 years, researchers included 266 patients who met the study criteria. At least 1 gadolinium-enhanced T1-weighted, or 9 or more of her T2-weighted brain lesions; Kurtzke Diastolic Impairment Status Scale score 0–5.0; John Cunningham’s viral index ≤1.5 his.
Participating patients were randomized 1:1 to receive intravenous infusions of 300 mg of either proposed natalizumab or reference natalizumab every 4 weeks. At week 24, her 30 patients in the reference group were re-randomized to the proposed group until the study was completed at week 44.
The mean age of the 264 patients was 36.7 years and 61.4% of the population were female. In the first part of the study, the proposed biosim-NTZ group consisted of 131 patients and the ref-NTZ group consisted of her 133 patients. .
A sensitivity analysis was employed to confirm these data, as well as a modified stratified factor analysis to examine the effects of false stratification and analyzes using multiple imputation.
After re-randomizing patients in the ref-NTZ arm, the investigator determined that there were no significant differences among the three treatment arms when assessing secondary efficacy endpoints, safety, or tolerability. I couldn’t get it. This includes secondary magnetic resonance imaging (MRI) and clinical outcome.
When the primary endpoint was assessed at week 24, the annual recurrence rate (ARR) in both arms was consistent with the prior AFFIRM Phase 3 trial of natalizumab, which had similar baseline population characteristics researchers focused on.
“The proposed biosim-NTZ PB006 is the first biosimilar monoclonal antibody therapy developed for MS,” they wrote. “Clinical efficacy, safety, and immunogenicity of the proposed biosimilar natalizumab were consistent with the reference natalizumab in the tested settings, and no clinically relevant differences were observed. This third Phase trial results support the biosimilarity of the proposed biosimilar natalizumab PB006 to the reference drug in the RRMS.”
“Efficacy and safety of a proposed biosimilar natalizumab (PB006) in patients with relapsing-remitting multiple sclerosis: The Antelope Phase 3 Randomized Clinical Trial” was published in . JAMA Neurology.