• The 40wks. comparative study of PDA10, a proposed epoetin alfa biosimilar & the reference Epogen showed comparable efficacy & safety in renal anemia in patients on hemodialysis. The study was conducted in multiple sites across Malaysia and Korea
• The primary efficacy EPs were similar i.e., change in Hb, weekly dose, or safety parameters b/w groups & 2EPs were also comparable b/w groups included change in hematocrit, patients with Hb levels within or out of the target range of 10-12 g/dL {111 (81.62%) vs 108 (90.0%)}, safety and immunogenicity
• Additionally, no anti-epoetin Abs were identified in either group at baseline or in the treatment phase, no differences in patients who experienced TEAEs

Ref: Centre for biosimilar | Image: CMOCRO