Bioequivalence of HX575 (recombinant human epoetin alfa) and a comparator epoetin alfa after multiple subcutaneous administrations

Pharmacology

Volumn 83, Issue 2, 2009, Pages 122-130

  Sörgel, Fritz ^a,d   Thyroff Friesinger, Ursula ^b   Vetter, Andrea ^b   Vens Cappell, Bernhard ^c   Kinzig, Martina ^a  

^a IBMP Institute for Biomedical and Pharmaceutical Research   (Germany)

^b Sandoz Biopharmaceuticals   (Germany)

^c Scope International   (Germany)

^d Institute for Biomedical and Pharmaceutical Research   (Germany)

Author keywords

Biosimilar erythropoesis stimulating agents; Epoetin; Erythropoesis stimulating agents; HX575, bioequivalence; HX575, subcutaneous administration; Pharmacodynamics; Pharmacokinetics; Recombinant human epoetin alfa

Indexed keywords

BINOCRIT; ERYPRO; HX 575; RECOMBINANT ERYTHROPOIETIN; RECOMBINANT HUMAN ERYTHROPOIETIN ALPHA; UNCLASSIFIED DRUG;

ADULT; AREA UNDER THE CURVE; ARTICLE; BACKACHE; BIOEQUIVALENCE; CLINICAL TRIAL; COMMON COLD; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DIZZINESS; DRUG BIOAVAILABILITY; DRUG ELIMINATION; DRUG HALF LIFE; DRUG SAFETY; DRUG TOLERABILITY; FATIGUE; HEADACHE; HUMAN; HUMAN EXPERIMENT; LEG PAIN; MALE; NAUSEA; NORMAL HUMAN; POLYCYTHEMIA; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; STEADY STATE; STOMACH PAIN;

ADULT; EPOETIN ALFA; HEMATINICS; HEMATOLOGIC TESTS; HEMOGLOBINS; HUMANS; INJECTIONS, SUBCUTANEOUS; MALE; RECOMBINANT PROTEINS; THERAPEUTIC EQUIVALENCY;

EID: 58149102254     PISSN: 00317012     EISSN: None     Source Type: Journal    
DOI: 10.1159/000189027     Document Type: Article

References (20)

1. Graber SE, Krantz SB: Erythropoietin and the control of red cell production. Ann Rev Med 1978;29:51-66.
2. Eschbach JW, Adamson JW: Anemia of endstage renal disease. Kidney Int 1985;28:1-5.
3. Eschbach JW, Egrie JC, Downing MR, Browne JK, Adamson JW: Correction of the anemia of end-stage renal disease with recombinant human erythropoietin. N Engl J Med 1987;316:73-78.
4. Eschbach JW, Abdulhadi MH, Browne JK, Delano BG, Downing MR, Egrie JC, Evans RW, Friedman EA, Graber SE, Haley NR, et al: Recombinant human erythropoietin in anemic patients with end-stage renal disease. Results of a phase III multicenter clinical trial. Ann Intern Med 1989;111:992-1000.
5. Eschbach JW, Egrie JC, Downing MR, Browne JK, Adamson JW: The use of recombinant human erythropoietin: effect in endstage renal disease; in Friedman EA, Beyer M, DeSanto NG, Giordano C (eds): Prevention of Chronic Uremia. Philadelphia, Field & Wood Inc., 1989, pp 148-155.
6. Egrie JC, Eschbach JW, McGuire T, Adamson JW: Pharmacokinetics of recombinant human erythropoietin administered to hemodialysis patients (abstract). Kidney Int 1988;33:262.
7. Evans RW, Rader B, Manninen DL: The quality of life of hemodialysis recipients treated with recombinant human erythropoietin. JAMA 1990;263:825-830.
8. Paganini E, Garcia J, Ellis P, Bodnar D, Magnussen M: Clinical sequelae of correction of anemia with recombinant human erythropoietin; urea kinetics, dialyzer function and reuse (abstract). Am J Kidney Dis 1988;11:16.
9. Delano BG, Lundin AP, Galonsky R, Quinn RM, Rao TK, Friedman EA: Dialyzer urea and creatinine clearances not significantly changed in r-HuEPO-treated maintenance hemodialysis patients (abstract). Kidney Int 1988;33:219.
10. Stivelman J, Van Wyck D, Ogden D: Use of recombinant erythropoietin with high flux dialysis does not worsen azotemia or shorten access survival (abstract). Kidney Int 1988;33:239.
11. Lim VS, DeGowin RL, Zavala D, Kirchner PT, Abels R, Perry P, Fangman J: Recombinant human erythropoietin treatment in pre-dialysis patients: a double-blind placebo-controlled trial. Ann Intern Med 1989;110:108-114.
12. Stone WJ, Graber SE, Krantz SB, Dessypris EN, O'Neil VL, Olsen NJ, Pincus TP: Treatment of the anemia of pre-dialysis patients with recombinant human erythropoietin: a randomized, placebo-controlled trial. Am J Med Sci 1988;296:171-179.
13. De Andrade JR, Jove M: Baseline hemoglobin as a predictor of risk of transfusion and response to epoetin alfa in orthopedic surgery patients. Am J Orthoped 1996;25:533-542.
14. Goldberg MA, McCutchen JW: A safety and efficacy comparison of two dosing regimens of epoetin alfa in patients undergoing major orthopedic surgery. Am J Orthoped 1996;25:544-552.
15. Faris PM, Ritter MA: The effects of recombinant human erythropoietin on perioperative transfusion requirements in patients having a major orthopaedic operation. J Bone Joint Surg Am 1996;78:62-72.
16. Nissenson AR, Swan SK, Lindberg JS, Soroka SD, Beatey R, Wang C, Picarello N, McDermott-Vitak A, Maroni BJ: Randomized, controlled trial of darbepoetin alfa for the treatment of anemia in hemodialysis patients. Am J Kidney Dis 2002;40:110-118.
17. Chow SC, Liu JP: Design and Analysis of Bioavailability and bioequivalence Studies. Hong Kong, Dekker, 1992.
18. Hollander M, Wolfe DA: Nonparametric Statistical Methods. The Two Sample Problem. New York, Wiley, 1973.
19. Hauschke D, Steinijans VW, Diletti E: A distribution-free procedure for the statistical analysis of bioequivalence studies. Int J Clin Pharmacol Ther Toxicol 1992;30(suppl 1):37-43.
20. Cheung W, Minton N, Gunawardena K: Pharmacokinetics and pharmacodynamics of epoetin alfa once weekly and three times weekly. Eur J Clin Pharmacol 2001;57:411-418.