Actorise (darbepoetin alfa biosimilar) / Cipla, Hetero - LARVOL DELTA

Comparison of darbepoetin alfa and epoetin alfa for the treatment of renal anaemia (GaBI) - P=NA, N=213; " In the ITT population the between group difference in mean Hb change was −0.01 g/dL (95% CI -0.68 to -0.66, p = 0.97). After adjusting for covariates, the difference was -0.2878 g/dL (95% CI -0.936 to 0.360). The lower limit of the two-sided 95% CI of the primary endpoint was above the pre-specified non-inferiority margin of -1.0 g/dL. A similar trend of non-inferiority was observed for the PP population."

Clinical data