UBI Pharma’s UB-851, a Biosimilar Short-Acting Recombinant Human Erythropoietin, Demonstrates Strong Clinical Biosimilarity and Earns Publication in an International Medical Journal
United BioPharma, Inc. (TWSE: 6562) announced that the Phase III Taiwan multicenter clinical trial results for its investigational product UB-851, a recombinant human erythropoietin biosimilar to Eprex®, have been published in the internationally recognized Journal of the Chinese Medical Association (JCMA), underscoring the product’s clinical value and biosimilar potential.
UB-851 is being developed as a biosimilar to Eprex® for the treatment of anemia associated with chronic kidney disease in patients who may require blood transfusions, as well as symptomatic anemia associated with cancer chemotherapy. The published article, entitled “Efficacy, safety, and immunogenicity of UB-851 versus Eprex® in patients with renal anemia receiving hemodialysis: A randomized, double-masked, phase III trial,” reported the findings of a randomized, double-masked Phase III study designed to evaluate therapeutic equivalence between UB-851 and Eprex® in maintaining target hemoglobin levels over 24 weeks, as well as safety and immunogenicity over 52 weeks.
According to the study results, UB-851 demonstrated clinical equivalence to Eprex® in efficacy, with a comparable safety profile reflected in a similar distribution of adverse events. No immunogenicity was observed in either treatment group. These findings support a high degree of biosimilarity between UB-851 and Eprex® and represent a meaningful endorsement of UB-851’s clinical value by JCMA.
As one of Taiwan’s most established and representative journals in clinical medicine, JCMA’s publication of the study marks an important academic validation of UB-851’s therapeutic potential. The publication is expected to serve as an important reference for future clinical use and treatment decisions, while further raising the product’s international visibility and supporting future expansion into global markets.
Erythropoietin is widely used in the treatment of renal anemia. According to 2022 data from the IQVIA (IMS Health) database, the global market for recombinant human erythropoietin was valued at approximately US$6.4 billion, of which the short-acting erythropoietin segment targeted by UB-851 accounted for approximately US$4.1 billion. The market opportunity is further supported by growing clinical demand in Taiwan. According to the 2024 Taiwan Kidney Disease Annual Report published by the National Health Research Institutes and the Taiwan Society of Nephrology, the number of prevalent dialysis patients in Taiwan reached 88,555 in 2022, while the number of newly initiated dialysis patients totaled 12,459. Among newly initiated dialysis patients aged 20 and above, more than 70% had used erythropoietin during the year prior to dialysis, highlighting substantial demand for erythropoietin-based therapies in the treatment of dialysis-related renal anemia.
Erythropoietin remains one of the standard therapies reimbursed under Taiwan’s National Health Insurance system for anemia treatment in adult hemodialysis patients. Against this backdrop, the reference product Eprex®, which has long relied on overseas supply, formally notified the market in 2025 of its global discontinuation. As a domestically developed biosimilar, UB-851 is currently the only locally manufactured product of its kind in Taiwan within the hematopoietic therapy category. The product is aligned with the core objective of strengthening domestic pharmaceutical manufacturing under Taiwan’s National Drug Resilience Strategy and supports broader policy initiatives aimed at localizing active pharmaceutical ingredient production and advancing the internationalization of generic and biosimilar medicines. UB-851 is therefore expected to contribute to a more stable supply of critical medicines, enhance the resilience of Taiwan’s healthcare system, and provide stronger safeguards for patient access and medication security.
With Phase III clinical data demonstrating a high degree of biosimilarity to Eprex®, UB-851 is expected, upon approval and launch in Taiwan, to deliver therapeutic performance consistent with the reference product. Supported by clinical research collaborations with major hospitals throughout Taiwan, United BioPharma believes UB-851 is well positioned for rapid entry into the domestic market and has the potential to benefit a broader population of adult hemodialysis patients suffering from anemia.