The Clinical Study Report of the phase III clinical trial of the recombinant human erythropoietin biosimilar drug UB-851 of UBI Pharma Inc. (Stock Code: 6562) has been completed, and the trial results are accordance with the expectations. The BLA application for marketing and medicine certificate in Taiwan will be submitted in the near future.
According to 2020 Kidney Disease in Taiwan, the number of patients with Chronic Kidney Disease (CKD) on dialysis in Taiwan was 84,615 (2018), and the 2020 the United States Renal Data System (USR03) indicated that the incidence of end-stage of CKD in Taiwan was 523 patients/million people (ranked first worldwide) and the prevalence of dialysis was 3,429 patients/million people (ranked first worldwide). The total medical expenditure for CKD was NT$56.2 billion (ranked first among all expenditure which covered by the National Health Insurance in 2020); furthermore, 84% was allocated for dialysis of CKD patients, amounting to a total of NT$47.2 billion. The number of dialysis visits per year reached 24 million. There is a huge demand for erythropoietin in the dialysis-related pharmaceutical market.
The erythropoietin UB-851 developed by UBI Pharma is indicated for the treatment of renal anemia. The phase III clinical trial is a multi-dose, randomized, double-blind and parallel-controlled design to compare the efficacy, safety and immunogenicity between UB-851 and the reference drug approved by the Food and Drug Administration, Ministry of Health and Welfare (TFDA), EprexÒ (originally developed by J&J). The subjects enrolled in the trial were 204 and assigned to the UB-851 and EprexÒ groups in a 2:1 ratio. The trial duration was 24 weeks and the safety, immunogenicity and efficacy equivalence to maintain the target hemoglobin levels of UB-851 and EprexÒ were compared. In addition, the safety and immunogenicity of UB-851 for long-term use for 52 weeks were also assessed in this study.
The results of the interim analysis of the phase III clinical trial of UB-851 indicate that the mean change in the hemoglobin level and the mean change in the weekly dose of erythropoietin (a primary efficacy endpoint) were statistically significant, showing UB-851 is equivalent to the EprexÒ.. When compared with the reference drug EprexÒ (within a 95% confidence interval), the subjects used in UB-851 showed a mean change in hemoglobin levels within the efficacy equivalence value of ±0.6g/dL and a mean change in the weekly dose of erythropoietin within the efficacy equivalence value of ±45 IU/kg. Secondary efficacy endpoint(s): No statistically significant difference was found between UB-851 and the reference drug in the frequency of blood transfusion and maintenance of hemoglobin levels in the subjects, indicating that the equivalence defined in the trial design and statistics was reached. The results of Clinical Study Report show no anti-erythropoietin antibodies were found in the UB-851 group, indicating that UB-851 is safe and no immunogenicity in long-term used.
UBI Pharma stated that the Clinical Study Report of the phase III clinical trial of the recombinant human erythropoietin drug UB-851 has been completed, and the review application for marketing and registration of biosimilar drugs in Taiwan will be submitted to the Taiwan Food and Drug Administration (TFDA) of the Ministry of Health and Welfare after the Clinical Study Report of the trial and documents of CMC required by the authority are in order.