UBI Pharma Inc. announced that it has recently signed a production agreement with EirGenix for its biosimilar UB-851 Erythropoietin (EPO).

UB-851 is mainly used for the treatment of renal anaemia, and has completed Phase III clinical trials. All clinical indicators are in line with expectations, and is currently undergoing a Rolling Review, and will subsequently apply to Taiwan's Food and Drug Administration (TFDA) for marketing approval.

According to the 2021 Annual Report on Kidney Disease in Taiwan, there were 86,840 patients undergoing dialysis for chronic kidney disease (CKD). The prevalence of dialysis has been steadily increasing, with an annual growth rate of 2% to 3% from 2015 to 2019. In 2019, the incidence rate of dialysis was 590 per million population for males and 468 per million population for females.

Notably, there were 12,475 new dialysis patients, indicating a rising trend in the number of individuals requiring dialysis. Additionally, the utilization of erythropoietin, a medication used to treat renal anemia in dialysis patients aged 20 years or older in the year before dialysis, has seen an increase. This suggests a substantial demand for erythropoietin within the pharmaceutical market to address the occurrence of renal anemia in dialysis patients. 

According to UBI, should UB-851 be approved in Taiwan, it will become the first homegrown erythropoietin biosimilar drug that will supply the needs of dialysis patients in the country. UBI has signed a contract for batch and commercial production of UB-851 with EirGenix, a pharmaceutical CDMO company and the only one in Taiwan with cGMP facilities certificated by FDA, PMDA (Japan), TGA (Australia) and TFDA for biologics manufacturing. EirGenix is also in the process of EMA certification. 

The partnership between UBI and EirGenix is expected to expedite the production and the launch of UB-851.