Biosimilar epoetin zeta: extrapolation of indications and real world utilization experience

References

• Gianoncelli A, Bonini SA, Bertuzzi M, et al. An integrated approach for a structural and functional evaluation of biosimilars: implications for erythropoietin. BioDrugs. 2015;29(4):285–300. doi:10.1007/s40259-015-0136-3.
   PubMed Web of Science ®Google Scholar
• Davis-Ajami ML, Wu J, Downton K, et al. Epoetin zeta in the management of anemia associated with chronic kidney disease, differential pharmacology and clinical utility. Biologics. 2014;8:155–167. doi:10.2147/BTT.S27578.
   PubMedGoogle Scholar
• Michallet M, Losem C. Biosimilar epoetin zeta in oncology and haematology: development and experience following 6 years of use. Acta Haematol. 2016;135(1):44–52. doi:10.1159/000438976.
   PubMed Web of Science ®Google Scholar
• Covic A, Abraham I. State-of-the-art biosimilar erythropoietins in the management of renal anemia: lessons learned from Europe and implications for US nephrologists. Int Urol Nephrol. 2015;47(9):1529–1539. doi:10.1007/s11255-015-1042-9.
   PubMed Web of Science ®Google Scholar
• Bressler B, Dingermann T. Establishing a new marketplace for biologic therapy with biosimilar agents: importance of extrapolation of data. Biosimilars. 2015;5:41–48.
   Google Scholar
• Weise M, Kurki P, Wolff-Holz E, et al. Biosimilars: the science of extrapolation. Blood. 2014;124(22):3191–3196. doi:10.1182/blood-2014-06-583617.
   PubMed Web of Science ®Google Scholar
• Schellekens H, Lietzan E, Faccin F, et al. Biosimilar monoclonal antibodies: the scientific basis for extrapolation. Expert Opin Biol Ther. 2015;15(11):1633–1646. doi:10.1517/14712598.2015.1083552.
   PubMed Web of Science ®Google Scholar
• Fishbane S, Shah HH. The emerging role of biosimilar epoetins in nephrology in the United States. Am J Kidney Dis. 2015;65(4):537–542. doi:10.1053/j.ajkd.2014.11.018.
   PubMed Web of Science ®Google Scholar
• Haag-Weber M, Eckardt K-U, Hörl WH, et al. Safety, immunogenicity and efficacy of subcutaneous biosimilar epoetin-α (HX575) in non-dialysis patients with renal anemia: a multi-center, randomized, double-blind study. Clin Nephrol. 2012 Jan;77(1):8–17.
   PubMed Web of Science ®Google Scholar
• Seidl A, Hainzl O, Richter M, et al. Tungsten-induced denaturation and aggregation of epoetin alfa during primary packaging as a cause of immunogenicity. Pharm Res. 2012 Jun;29(6):1454–1467. doi:10.1007/s11095-011-0621-4.
   PubMed Web of Science ®Google Scholar
• Zeid RL. Regulatory and development issues in the demonstration of therapeutic equivalence for multisource biotech-derived pharmaceuticals. Drug Info J. 2000;34:919–959.
   Google Scholar
• Halim LA, Brinks V, Jiskoot W, et al. Quality and batch-to-batch consistency of original and biosimilar epoetin products. J Pharm Sci. 2016;105:542–550. doi:10.1016/j.xphs.2015.10.019.
   PubMed Web of Science ®Google Scholar
• Schiestl M, Stangler T, Torella C, et al. Acceptable changes in quality attributes of glycosylated biopharmaceuticals. Nat Biotechnol. 2011;29:310–312. doi:10.1038/nbt.1867.
   PubMed Web of Science ®Google Scholar
• Schneider CK. Biosimilars in rheumatology: the wind of change. Ann Rheum Dis. 2013;72(3):315–318. doi:10.1136/annrheumdis-2012-202941.
   PubMed Web of Science ®Google Scholar
• Retacrit EPAR. Retacrit EPAR summary for the public. 2007 [cited 2015 Aug 13]. Available from: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000872/human_med_001031.jsp&mid=WC0b01ac058001d124.
   Google Scholar
• Dellanna F, Fluck RJ, Lonnemann G, et al. Results from a safety cohort of patients with renal anemia receiving the biosimilar epoetin zeta: the PASCO I study. Clin Nephrol. 2015;84(5):280–288. doi:10.5414/CN108484.
   PubMed Web of Science ®Google Scholar
• Reticrit product utilization report. Data on file. Lake Forest (IL): Hospira (a Pfizer company); 2015.
   Google Scholar
• Extrapolation of indications in biosimilars: epoetin. GABI online posted 12/12/2014 [cited 2016 Mar 28]. Available from: http://www.gabionline.net/Biosimilars/Research/Extrapolation-of-indications-in-biosimilars-epoetin.
   Google Scholar
• PASCO II [cited 2016 Mar 28]. Available from: https://clinicaltrials.gov/ct2/show/NCT01543477?term=pasco+ii&rank=1.
   Google Scholar
• GaBI Online – Generics and Biosimilars Initiative. Biosimilars in the treatment of chemotherapy-induced anaemia [http://www.gabionline.net]. Mol: Pro Pharma Communications International [rivesed 2016 Mar 28; cited 2014 Dec 12]. Available from: www.gabionline.net/Biosimilars/Research/Biosimilars-in-the-treatment-of-chemotherapy-induced-anaemia.
   Google Scholar
• GaBI Online – Generics and Biosimilars Initiative. Positive post-marketing data for biosimilar epoetin [http://www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International [cited 2016 Mar 28]. Available from: www.gabionline.net/Biosimilars/Research/Positive-post-marketing-data-for-biosimilar-epoetin.
   Google Scholar
• Minutolo R, Borsumati M, Sposini S, et al. Dosing penalty of erythropoiesis-stimulating agents after switching from originator to biosimilar preparations in stable hemodialysis patients. Amer J Kid Dis. 2016. [ Epub ahead of print]
   Google Scholar
• Michallet M, Luporsi E, Soubeyran P, et al. BiOsimilaRs in the management of anaemia secondary to chemotherapy in HaEmatology and Oncology: results of the ORHEO observational study. BMC Cancer. 2014;14(1):503. doi:10.1186/1471-2407-14-503.
   PubMed Web of Science ®Google Scholar
• Auerbach M, Ballard H, Trout JR, et al. Intravenous iron optimizes the response to recombinant human erythropoietin in cancer patients with chemotherapy-related anemia: a multicenter, open-label, randomized trial. J Clin Oncol. 2004;22:1301–1307. doi:10.1200/JCO.2004.08.119.
   PubMed Web of Science ®Google Scholar
• Hedenus M, Birgegård G, Näsman P, et al. Addition of intravenous iron to epoetin beta increases hemoglobin response and decreases epoetin dose requirement in anemic patients with lymphoproliferative malignancies: a randomized multicenter study. Leukemia. 2007;21:627.
   PubMed Web of Science ®Google Scholar
• Henry DH, Dahl NV, Auerbach M, et al. Intravenous ferric gluconate significantly improves response to epoetin alfa versus oral iron or no iron in anemic patients with cancer receiving chemotherapy. Oncologist. 2007;12:231–242. doi:10.1634/theoncologist.12-2-231.
   PubMed Web of Science ®Google Scholar
• Bastit L, Vandebroek A, Altintas S, et al. Randomized, multicenter, controlled trial comparing the efficacy and safety of darbepoetin alpha administered every 3 weeks with or without intravenous iron in patients with chemotherapy-induced anemia. J Clin Oncol. 2008;26:1611. doi:10.1200/JCO.2007.15.2777.
   PubMed Web of Science ®Google Scholar
• Pedrazzoli P, Farris A, Del Prete S, et al. Randomized trial of intravenous iron supplementation in patients with chemotherapy-related anemia without iron deficiency treated with darbepoetin alpha. J Clin Oncol. 2008;26:1619. doi:10.1200/JCO.2007.15.2777.
   PubMed Web of Science ®Google Scholar
• Auerbach M, Silberstein PT, Webb RT, et al. Darbepoetin alfa 300 or 500 μg once every 3 weeks with or without intravenous iron in patients with chemotherapy-induced anemia. Am J Hematol. 2010;85:655. doi:10.1002/ajh.21779.
   PubMed Web of Science ®Google Scholar
• Steensma DP. Art of oncology: new voices wanted. J Clin Oncol. 2011;29:97. doi:10.1200/JCO.2010.30.3644.
   PubMed Web of Science ®Google Scholar
• Scotte F, Laribi K, Gisselbrecht C, et al. Real-life efficacy of an epoetin alfa biosimilar in chemotherapy-induced anemia. Poster 373D. ESMO. Ann Onc. 2015;26(S9):112.
   Google Scholar
• Aapro MS, Link H. September 2007 update on EORTC guidelines and anemia management with erythropoiesis-stimulating agents. Oncologist. 2008;13(S3):33–36. doi:10.1634/theoncologist.13-S3-33.
   PubMed Web of Science ®Google Scholar
• Bokemeyer C, Aapro MS, Courdi A, et al.; European Organisation for Research and Treatment of Cancer (EORTC) Taskforce for the Elderly. EORTC guidelines for the use of erythropoietic proteins in anaemic patients with cancer: 2006 update. Eur J Cancer. 2007;43:258–270. doi:10.1016/j.ejca.2006.10.014.
   PubMed Web of Science ®Google Scholar
• Samama MM, Dahl OE, Quinlan DJ, et al. Quantification of risk factors for venous thromboembolism: a preliminary study for the development of a risk assessment tool. Haematologica. 2003 Dec;88(12):1410–1421 .
   PubMed Web of Science ®Google Scholar
• Goodnough LT, Maniatis A, Earnshaw P, et al. Detection, evaluation, and management of preoperative anaemia in the elective orthopaedic surgical patient: NATA guidelines. Brit J Anesth. 2011;106(1):13–22. doi:10.1093/bja/aeq361.
   PubMed Web of Science ®Google Scholar
• Rosencher N, Debaene B, Sautet A, et al. Safety and efficacy of epoetin zeta before major orthopedic surgery. Poster A3048 Presented October 26, 2015 at Amer Soc Anesth [cited 2016 Jan 1]. Available from: http://www.asaabstracts.com/strands/asaabstracts/abstract.htm;jsessionid=65BF63496AE844E6710C5D4EC19FE188?year=2015&index=4&absnum=3947.
   Google Scholar
• McKeage K. A review of CT-P13: an infliximab biosimilar. BioDrugs. 2014;28(3):313–321. doi:10.1007/s40259-014-0094-1.
   PubMed Web of Science ®Google Scholar
• Davis-Ajami ML, Wu J, Downton K. Epoetin zeta in the management of anemia associated with chronic kidney disease, differential pharmacology and clinical utility. Biologics. 2014;8:155–167.
   PubMedGoogle Scholar
• Dellanna F, Fluck RJ, Lonnemann G, et al. Results from a safety cohort of patients with renal anemia receiving the biosimilar epoetin zeta: the PASCO I study. Clin Nephrol. 2015 Nov;84(5):280–288. doi:10.5414/CN108484.
   PubMed Web of Science ®Google Scholar
• Mikhail A, Farouk M. Epoetin biosimilars in Europe: five years on. Adv Ther. 2013;30(1):28–40. doi:10.1007/s12325-012-0072-2.
   PubMed Web of Science ®Google Scholar
• Rossert J, Casadevall N, Eckardt K-U. Anti-erythropoietin antibodies and pure red cell aplasia. J Am Soc Nephrol. 2004;15(2):398–406.
   PubMed Web of Science ®Google Scholar
• Jarrett S, Dingermann T. Biosimilars are here: a hospital pharmacist’s guide to educating health care professionals on biosimilars. Hosp Pharm. 2015;50:884–893. doi:10.1310/hpj5010-884.
   PubMedGoogle Scholar
• Hörbrand F, Rottenkolber D, Fischaleck J. Erythropoietin-induced treatment costs in patients suffering from renal anemia – a comparison between biosimilar and originator drugs. Gesundheitswesen. 2014 Nov;76(11):e79–e84. doi:10.1055/s-0033-1361111.
   Google Scholar
• Krivoshiev S, Wizemann V, Czekalski S, et al. Therapeutic equivalence of epoetin zeta and alfa, administered subcutaneously, for maintenance treatment of renal anemia. Adv Ther. 2010 Feb;27(2):105–117. doi:10.1007/s12325-010-0012-y.
   PubMed Web of Science ®Google Scholar
• Tzekova V, Mihaylov G, Elezovic I, et al.; Epoetin Zeta Oncology Study Group. Therapeutic effects of epoetin zeta in the treatment of chemotherapy-induced anaemia. Curr Med Res Opin. 2009 Jul;25(7):1689–1697. doi:10.1185/03007990903050876.
   PubMed Web of Science ®Google Scholar
• Baldamus C, Krivoshiev S, Wolf-Pflugmann M, et al. Long-term safety and tolerability of epoetin zeta, administered intravenously, for maintenance treatment of renal anemia. Adv Ther. 2008 Nov;25(11):1215–1228. doi:10.1007/s12325-008-0111-1.
   PubMed Web of Science ®Google Scholar
• Kirkov V, Dimitrova V, Siebert-Weigel M, et al. Evaluation of the pharmacokinetics of two recombinant human erythropoietin preparations: epoetin zeta and epoetin alfa. 2nd communication: a monocentric, double-blind, randomized, single dose, three-period crossover trial in healthy volunteers. Arzneimittelforschung. 2008;58(5):220–224. doi:10.1055/s-0031-1296498.
   PubMed Web of Science ®Google Scholar
• Kirkov V, Dimitrova V, Siebert-Weigel M, et al. Evaluation of the pharmacokinetics of two recombinant human erythropoietin preparations: epoetin zeta and epoetin alfa. 1st communication: a monocentric, open, randomized, single dose, two-period crossover trial in healthy volunteers. Arzneimittelforschung. 2008;58(5):215–219. doi:10.1055/s-0031-1296497.
   PubMed Web of Science ®Google Scholar
• Krivoshiev S, Todorov VV, Manitius J, et al. Comparison of the therapeutic effects of epoetin zeta and epoetin alpha in the correction of renal anaemia. Curr Med Res Opin. 2008 May;24(5):1407–1415. doi:10.1185/030079908X297402.
   PubMed Web of Science ®Google Scholar
• Wizemann V, Rutkowski B, Baldamus C, et al. Comparison of the therapeutic effects of epoetin zeta to epoetin alfa in the maintenance phase of renal anaemia treatment. Curr Med Res Opin. 2008 Mar;24(3):625–637. doi:10.1185/030079908X273264.
   PubMed Web of Science ®Google Scholar