UBI Pharma Inc. (6562.TW) made an announcement today, on the 2nd of the month, regarding its self-developed biosimilar drug UB-851, which is an erythropoietin analog. The company has entered into a production agreement with EirGenix, marking the official commencement of its expansion into the international market.
UBI Pharma Inc. emphasized that UB-851 is primarily intended for the treatment of renal anemia and has successfully completed Phase III clinical trials. All clinical trial results have met expectations, and the drug is currently undergoing a Rolling Review for pre-registration batch inspection. Subsequently, the company intends to apply for registration and approval of the biosimilar with the Taiwan Food and Drug Administration (TFDA).
According to the 2021 Kidney Disease Annual Report, Taiwan has 86,840 prevalent dialysis patients, with an annual increase in prevalence rates of approximately 2% to 3% from 2015 to 2019. In 2019, the dialysis incidence rate was 590 per million population for males and 468 for females. The number of new dialysis patients was 12,475, indicating a growing trend. Moreover, there has been an increase in the use of erythropoietin before dialysis among new patients aged 20 and above. This underscores the substantial demand for erythropoietin in the treatment of renal anemia and other related conditions within the pharmaceutical market. According to data from the IQVIA (IMS Health) database for 2022, the global market for recombinant human erythropoietin is valued at approximately $6.4 billion, with UB-851 targeting the short-acting erythropoietin segment, accounting for about $4.1 billion of the global market.
UBI Pharma Inc. also highlighted that if UB-851 obtains approval from Taiwan, it will become the first domestically produced erythropoietin biosimilar, addressing the needs of domestic kidney disease patients. The collaboration between Uni-Pharma and Taiwan-Kang BioTech for the large-scale production of UB-851 active pharmaceutical ingredients is intended to facilitate early deployment of a scalable active pharmaceutical ingredient supplier, focusing on technology transfer, capacity optimization, and the expansion of commercial production for the secondary supplier.
This partnership between UBI Pharma Inc. and EirGenix for the production of UB-851 active pharmaceutical ingredients is expected to expedite international production permits and certifications for the product. Beyond being an exemplary collaboration within the Taiwanese biopharmaceutical industry, it also underscores Taiwan’s influence in the biopharmaceutical sector, ultimately benefiting global patients more expeditiously.
