Comparative Study cf Biosimilar Genolar® Clinical Efficacy оп the Randomized Phase III Study Results

Abstract

There are results of a comparative phase III clinical study on the efficiency and safety of the biosimilar drug Genolar® (Generium JSC, Russia) and the reference drug Xolair® (Novartis Pharma AG, Switzerland) ((NCT04607629). The study is aimed to establish the clinical equivalence of the compared drugs for additional therapy of patients with moderate and severe bronchial asthma (BA) are considered in the article. Methods. The study enrolled 191 patients aged 18 to 75 years with a moderate to severe atopic asthma for ≥ 1 year, the symptoms of which were insufficiently controlled by therapy corresponding to the 4 th stage of treatment (GINA, 2017) for ≥ 2 months before the screening. Patients were divided into the two groups in a ratio of 2 : 1 with the block randomization. 127 patients of the Group 1 were administered Genolar® for 52 weeks ± 3 days; 64 patients of the Group 2 were administered Xolair® for 26 weeks ± 3 days. The dose and frequency of the compared drugs administration were determined based both the initial IgE concentration (IU/mL) measured before treatment and the current body weight (kg) of the patient. The recommended omal-izumab dose was 75 to 600 mg once every 2 or 4 weeks. The primary efficacy endpoint was the patients’ percentage with a physician evaluation of “excellent” or “good” on the Global Evaluation of Treatment Effectiveness (GETE) scale after 26 weeks of comparative treatment. Results. According to the data analysis results, the patients’ proportion with a GETE score of “excellent” or “good” after 26 weeks of therapy were no statistically significant differences between the groups in both investigated populations (PP-population (per protocol) and FAS-population (full analyses set)) (p > 0.05). Primary efficacy endpoint data analysis showed that the patients’ proportion of the PP population with a GETE score of “excellent” or “good” was 57.4% of the Group 1 and 45.2% of the Group 2 (p = 0.132). The calculated one-sided 95% CI in order to test the study statistical hypothesis showed that the investigated drug Genolar® (Generium JSC, Russia) is “non-inferior” than the reference drug. The PP population onesided 95% CI was from -0.5 to 25.0% (p = 0.116), the FAS population one was from -1.1 to 24.2% (p = 0.134). According to the safety analysis results, the comparability of the investigated and reference drugs in terms of the frequency of the adverse events was demonstrated. The analysis results of the anti-drug antibodies to omalizumab detection revealed the antibody production absence in response to the administration of the studied drugs. Conclusion. The clinical study results have proved the equivalence of the biological analogue Genolar® (Generium JSC, Russia) and the reference drug Xolair® (Novartis Pharma AG, Switzerland).