Clinical evaluation in adult human revealed the biosimilarity of recombinant Erythropoietin GBPD002 with Eprex®

Author(s): Mamun Al Mahtab, Sitesh Chandra Bachar, Kakon Nag, Mohammad Mohiuddin, Md. Abdur Rahim, Md. Helal Uddin, Samir Kumar, Md. Maksudur Rahman Khan, Md. Enamul Haq Sarker, Rony Roy, Sourav Chakraborty, Bipul Kumar Biswas, Md. Emrul Hasan Bappi, Ratan Roy, Uttam Barman and Naznin Sultana

The biosimilarity for erythropoietin (EPO) functionality of GBPD002 (test candidate) and Eprex® (comparator) has been evaluated by comparing the pharmacokinetic (PK) and pharmacodynamic (PD) properties following subcutaneous injection. This was a randomized, double-blinded, twosequence, crossover clinical trial. Subjects were randomly assigned and received a dose (4,000 IU) of either the test or comparator EPO, and received the alternative formulations after 4-weeks of washout period. The PK parameters, viz., maximum observed concentration (Cmax) and area under the curve extrapolated to infinity (AUC0-inf), were calculated with the serum EPO concentrations from blood samples and were found comparable for both formulations. The geometric mean ratios (at 90% CI) of the Cmax and AUCinf were 0.89 and 1.16, respectively, which were within the regulatory range of 0.80 – 1.25. The time-matched serum EPO concentrations and PD markers (reticulocyte, hematocrit, hemoglobin, and red blood cell) denoted a counter-clockwise hysteresis, suggesting a time delay between the observed concentration and the response. ANOVAderived p-value (>0.05) for the effectors clearly revealed the similarity between effects on PD markers for the test and comparator drugs. Both formulations were found tolerated well, and anti-drug antibodies were not observed. Thus, the two formulations are projected to be used interchangeably in clinical settings.

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