title: Evaluation of a biosimilar recombinant alpha epoetin in the management of anemia in hemodialysis patients.
abstract: BACKGROUND
  The efficacy of human recombinant erythropoietins (rHuEPOs) in the treatment of anemia with different etiologies is proven. Development of biosimilar rHuEPO products with lower cost and wider availability is important for the care of anemic patients.
  
  
  OBJECTIVE
  The aim of the present study was to determine the bioequivalence and safety of a biosimilar rHuEPO (Pastopoitin(®)) and compare it with the innovator product Eprex(®), as a standard rHuEPO.
  
  
  METHODS
  One hundred and seven anemic patients on stable hemodialysis were recruited to this randomized double-blind comparative trial and assigned to either subcutaneous Pastopoitin (n = 50) or Eprex (n = 57). Each study group received rHuEPO at a dose of 80-120 IU/kg/week in 2-3 divided doses for a period of 3 months. Hematologic parameters including Hemoglobin, hematocrit, RBC, EBC, platelet, MCV, MCH and MCHC were checked every 2 weeks. Blood iron, ferritin, TIBC, creatinine, BUN and electrolytes (Na, K, Ca and P) were evaluated monthly over the 3 months.
  
  
  RESULTS
  A significant increase in hemoglobin, hematocrit and RBC was observed by the end of study in both Pastopoitin and Eprex groups (p < 0.001). However, these factors were not significantly different between the groups, neither at baseline nor at the end of study (p > 0.05). Likewise, the groups were comparable regarding MCV, MCH, MCHC, iron, ferritin, TIBC, creatinine, BUN and electrolytes at baseline as well as at the end of trial. Adverse events were not serious and occurred with the same frequency in the study groups.
  
  
  CONCLUSIONS
  Pastopoitin showed comparable efficacy and safety profile with Eprex in anemic patients on hemodialysis. Hence, Pastopoitin may be considered as a rHuEPO with a lower cost and wider availability compared with the innovator product Eprex.
authors.affiliation: Nephrology and Urology Research Center, Baqiyatallah University of Medical Sciences, Tehran, Iran.
authors.forename: Fatemeh
authors.initials: F
authors.lastname: Beiraghdar
authors.affiliation: Research Center of Chemical Injuries, Baquyatallah University of Medical Sciences, Tehran, Iran.
authors.forename: Yunes
authors.initials: Y
authors.lastname: Panahi
authors.affiliation: Nephrology and Urology Research Center, Baqiyatallah University of Medical Sciences, Tehran, Iran.
authors.forename: Behzad
authors.initials: B
authors.lastname: Einollahi
authors.affiliation: Nephrology and Urology Research Center, Baqiyatallah University of Medical Sciences, Tehran, Iran.
authors.forename: Eghlim
authors.initials: E
authors.lastname: Nemati
authors.affiliation: Biotechnology Research Center, Mashhad University of Medical Sciences, Mashhad, Iran ; Neurogenic Inflammation Research Center, Department of Medical Biotechnology, Mashhad University of Medical Sciences, Mashhad, Iran.
authors.forename: Amirhossein
authors.initials: A
authors.lastname: Sahebkar
authors.affiliation: Nephrology and Urology Research Center, Baqiyatallah University of Medical Sciences, Tehran, Iran.
authors.forename: Arash
authors.initials: A
authors.lastname: Hassanzadeh
authors.affiliation: Department of Nephrology, Tabriz University of Medical Sciences, Tabriz, Iran.
authors.forename: Hamid T
authors.initials: HT
authors.lastname: Khosroshahi
authors.affiliation: Department of Nephrology, Tabriz University of Medical Sciences, Tabriz, Iran.
authors.forename: Sima A
authors.initials: SA
authors.lastname: Azar
authors.affiliation: Department of Nephrology, Tabriz University of Medical Sciences, Tabriz, Iran.
authors.forename: Javid
authors.initials: J
authors.lastname: Safa
authors.affiliation: Department of Nephrology, Tabriz University of Medical Sciences, Tabriz, Iran.
authors.forename: Sadroddin R
authors.initials: SR
authors.lastname: Hashemi
authors.affiliation: Department of Nephrology, Tabriz University of Medical Sciences, Tabriz, Iran.
authors.forename: Jalal
authors.initials: J
authors.lastname: Etemadi
authors.affiliation: Nephrology and Urology Research Center, Baqiyatallah University of Medical Sciences, Tehran, Iran.
authors.forename: Eisa T
authors.initials: ET
authors.lastname: Marzony
authors.affiliation: Department of Nephrology, Tabriz University of Medical Sciences, Tabriz, Iran.
authors.forename: Hamid
authors.initials: H
authors.lastname: Noshad
keywords: Anemia; Biosimilar; Eprex; Hemodialysis; Pastopoitin