Randomized trial on the therapeutic equivalence between Eprex and GerEPO in patients on haemodialysis.
OBJECTIVE
Treatment of renal anaemia with epoetin is well established. However, epoetin is expensive. Biogeneric epoetin with proven efficacy would reduce cost and improve access to therapy. We conducted this first ever comparative study of a biogeneric and the original product.


METHODS
Stable haemodialysis patients with haemoglobin (Hb) of at least 9 g/dL and receiving the human recombinant erythropoietin Eprex were randomized to continue Eprex or convert to GerEPO, a biogeneric epoetin, for 12 weeks. The primary efficacy variable was a change in Hb from baseline.


RESULTS
Ninety-three subjects were randomized to each arm. Ninety-two and 87 subjects on the Eprex and GerEPO arms, respectively, completed the trial. Mean Hb in both groups declined over time. The mean decline in Hb was -0.47 g/dL in the Eprex group and -0.45 g/dL in the GerEPO group. The mean difference in the change in Hb from baseline to week 12 between the two groups was 0.02. The 95% confidence interval was -0.42 to 0.46, which lies within the margin of equivalence (+/-0.5 g/dL). The results of intention-to-treat analysis were similar. There were no significant differences in the epoetin dose, iron therapy or iron stores between the groups. Patients receiving GerEPO reported more adverse events.


CONCLUSIONS
GerEPO was therapeutically equivalent to Eprex with respect to Hb response for patients with Hb in the subtherapeutic target range as is common in this study population. The trial duration was insufficient for safety evaluation, which must await further investigation. More biogeneric products should be subjected to rigorous evaluation.
Goh
Bak-Leong
BL
Department of Nephrology, Serdang Hospital, Kuala Lumpur, Malaysia.
Ong
Loke-Meng
LM
Sivanandam
Sarojini
S
Lim
Teck-Onn
TO
Morad
Zaki
Z
D000328:Adult; D000740:Anemia / Q000097:blood / Q000188:drug therapy* / Q000209:etiology*; D004305:Dose-Response Relationship, Drug; D000068817:Epoetin Alfa; D004921:Erythropoietin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006397:Hematinics / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006454:Hemoglobins / Q000378:metabolism*; D006801:Humans; D007275:Injections, Intravenous; D007501:Iron / Q000008:administration & dosage / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D011994:Recombinant Proteins; D006435:Renal Dialysis / Q000009:adverse effects*; D016896:Treatment Outcome