The safety of switching between therapeutic proteins

Expert Opinion on Biological Therapy

Volumn 12, Issue 11, 2012, Pages 1473-1485

  Ebbers, Hans C ^a   Muenzberg, Michael ^b   Schellekens, Huub ^a,c  

^a UTRECHT UNIVERSITY   (Netherlands)

^b Sandoz Pharma Ltd   (Switzerland)

^c UTRECHT UNIVERSITY   (Netherlands)

Author keywords

Biopharmaceuticals; Biosimilars; Erythropoietin; Filgrastim; G CSF; Growth hormone; Safety; Switch; Switching

Indexed keywords

BIOSIMILAR AGENT; GLYCERYL TRINITRATE; HUMAN GROWTH HORMONE; NOVEL ERYTHROPOIESIS STIMULATING PROTEIN; RECOMBINANT ERYTHROPOIETIN; RECOMBINANT GRANULOCYTE COLONY STIMULATING FACTOR; ERYTHROPOIETIN; RECOMBINANT PROTEIN;

DATA BASE; DRUG SAFETY; DRUG SUBSTITUTION; DRUG SURVEILLANCE PROGRAM; DRUG WITHDRAWAL; GROWTH HORMONE DEFICIENCY; HEMODIALYSIS; HEMODIALYSIS PATIENT; HUMAN; MEDICATION ERROR; PERITONEAL DIALYSIS; RANDOMIZED CONTROLLED TRIAL (TOPIC); REVIEW; UNSPECIFIED SIDE EFFECT; ADVERSE EFFECTS; ANIMAL; CLINICAL TRIAL (TOPIC); FACTUAL DATABASE; PHARMACEUTICS; TRENDS;

ANIMALS; BIOPHARMACEUTICS; BIOSIMILAR PHARMACEUTICALS; CLINICAL TRIALS AS TOPIC; DATABASES, FACTUAL; DRUG SUBSTITUTION; ERYTHROPOIETIN; HUMANS; PHARMACOVIGILANCE; RECOMBINANT PROTEINS;

EID: 84867307195     PISSN: 14712598     EISSN: None     Source Type: Journal    
DOI: 10.1517/14712598.2012.711308     Document Type: Review

References (84)

1. Knezevic I, Griffiths E. Biosimilars-global issues, national solutions. Biologicals 2011;39(5):252-5
2. Weise M, Bielsky MC, De Smet K, et al. Biosimilars-why terminology matters. Nat Biotechnol 2011;29(8):690-3
3. European Medicines Agency. Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues. EMEA/CHMP/BMWP/42832/2005, Available from: http://www.ema.europa.eu/docs/en-GB/document-library/Scientific-guideline/2009/ 09/WC500003920.pdf [Accessed, July 16th 2012]
4. Dranitsaris G, Amir E, Dorward K. Biosimilars of biological drug therapies: regulatory, clinical and commercial considerations. Drugs 2011; 71(12):1527-36
5. World Health Organisation. WHO Technical Report Series, No. 937, 2006. Annex 7: Multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability. 2006. Available from: http://apps.who.int/prequal/info-general/documents/TRS937/WHO-TRS-937-annex7- eng.pdf [Accessed 25 June 2012]
6. Covic A, Cannata-Andia J, Cancarini G, et al. Biosimilars and biopharmaceuticals: what the nephrologists need to know - a position paper by the ERA-EDTA Council. Nephrol Dial Transplant 2008;23(12):3731-7
7. Niederwieser D, Schmitz S. Biosimilar agents in oncology/haematology: from approval to practice. Eur J Haematol 2011;86(4):277-88
8. Grimberg A, Feudtner C, Gordon CM. Consequences of brand switches during the course of pediatric growth hormone treatment. Endocr Pract 2012;18(3):307-16
9. Minghetti P, Rocco P, Del Vecchio L, Locatelli F. Biosimilars and regulatory authorities. Nephron Clin Pract 2011;117(1):c1-7
10. Barosi G, Bosi A, Abbracchio MP, et al. Key concepts and critical issues on epoetin and filgrastim biosimilars. A position paper from the Italian Society of Hematology, Italian Society of Experimental Hematology, and Italian Group for Bone Marrow Transplantation. Haematologica 2011;96(7):937-42
11. College voor Zorgverzekeringen. Preferentiebeleid biologische geneesmiddelen. 2011. Available from: http://www.cvz.nl/binaries/live/ cvzinternet/hst-content/nl/documenten/standpunten/2011/sp1109-preferentiebeleid- biologischegeneesmiddelen.pdf [Accessed 15 June 2012]
12. European Medicines Agency. Volume 9A of the rules governing medicinal products in the european union. 2008. Available from: http://ec.europa.eu/ enterprise/pharmaceuticals/eudralex/vol-9/pdf/vol9a-09-2008.pdf [Accessed 2 August 2011]
13. Wysowski DK, Swartz L. Adverse drug event surveillance and drug withdrawals in the United States, 1969-2002: the importance of reporting suspected reactions. Arch Intern Med 2005;165(12):1363-9
14. Hazell L, Shakir SA. Under-reporting of adverse drug reactions : a systematic review. Drug Saf 2006;29(5):385-96
15. Rovira J, Espin J, Garcia L, Olry de Labry A. The impact of biosimilars' entry in the EU market. 2011; Available from: http://ec.europa.eu/enterprise/ sectors/healthcare/files/docs/biosimilars-market-012011-en.pdf [Accesed July 17th 2012]
16. IMS Health. Shaping the biosimilars opportunity: A global perspective on the evolving biosimilars landscape. 2011. Available from: http://www.imshealth. com/ims/Global/Content/Home%20Page%20Content/IMS%20News/Biosimilars-Whitepaper. pdf [Accessed, 11 April 2012]
17. Loiacono C, Sgroi C, Coppolino S, et al. How much are biosimilars used in southern italy?: a retrospective analysis of epoetin utilization in the local health unit of messina in the years 2010-2011. BioDrugs 2012;26(2):113-20
18. Nurko S, Spirko R, Law A, Dennis VW. Dosing intervals and hemoglobin control in patients with chronic kidney disease and anemia treated with epoetin alfa or darbepoetin alfa: a retrospective cohort study. Clin Ther 2007;29(9):2010-21
19. Biggar P, Ketteler M, Hennemann H, Domling R. Switch of ESA therapy from darbepoetin-alpha to epoetin-beta in hemodialysis patients: a single-center experience. Clin Nephrol 2008; 69(3):185-92
20. Shalansky K, Jastrzebski J. Complete switch to darbepoetin in a hemodialysis unit. Clin Nephrol 2005;64(1):55-63
21. Nelson WW, Frear RS. Physician attitudes toward human growth hormone products. Am J Health Syst Pharm 1999;56(1):51-6
22. Hadji P, Kostev K, Schroder-Bernhardi D, Ziller V. Cost comparison of outpatient treatment with granulocyte colony-stimulating factors (G-CSF) in Germany. Int J Clin Pharmacol Ther 2012;50(4):281-9
23. Whalen CR, Watson TL, Baize T, Ball A. Formulary management of colony-stimulating factors. Am J Health Syst Pharm 2002;59(7 Suppl 2):S21-7
24. Brinks V, Hawe A, Basmeleh AH, et al. Quality of original and biosimilar epoetin products. Pharm Res 2011; 28(2):386-93
25. Meredith P. Bioequivalence and other unresolved issues in generic drug substitution. Clin Ther 2003; 25(11):2875-90
26. Haag-Weber M, Eckardt KU, Horl WH, et al. Safety, immunogenicity and efficacy of subcutaneous biosimilar epoetin-alpha (HX575) in non-dialysis patients with renal anemia: a multi-center, randomized, double-blind study. Clin Nephrol 2012;77(1):8-17
27. Valensi P, Benroubi M, Borzi V, et al. Initiating insulin therapy with, or switching existing insulin therapy to, biphasic insulin aspart 30/70 (NovoMix 30) in routine care: safety and effectiveness in patients with type 2 diabetes in the IMPROVE observational study. Int J Clin Pract 2009;63(3):522-31
28. D'Haens GR, Panaccione R, Higgins PD, et al. The London position statement of the world congress of gastroenterology on biological therapy for ibd with the european crohn's and colitis organization: when to start, when to stop, which drug to choose, and how to predict response? Am J Gastroenterol 2011;106(2):199-212; quiz 213
29. Ormerod AD. Switching biologics for psoriasis. Br J Dermatol 2010; 163(4):667-9
30. Van Assche G, Vermeire S, Ballet V, et al. Switch to adalimumab in patients with Crohn's disease controlled by maintenance infliximab: prospective randomised SWITCH trial. Gut 2012;61(2):229-34
31. Laursen T, Jorgensen JO, Susgaard S, et al. Subcutaneous absorption kinetics of two highly concentrated preparations of recombinant human growth hormone. Ann Pharmacother 1993;27(4):411-15
32. Vahl N, Jensen SB, Rasmussen MH, et al. Bioavailability of recombinant human growth hormone in different concentrations and formulations. Pharmacol Toxicol 1996;79(3):144-9
33. Jacobsen LV, Rolan P, Christensen MS, et al. Bioequivalence between ready-to-use recombinant human growth hormone (rhGH) in liquid formulation and rhGH for reconstitution. Growth Horm IGF Res 2000;10(2):93-8
34. Bidlingmaier M, Kim J, Savoy C, et al. Comparative pharmacokinetics and pharmacodynamics of a new sustained-release growth hormone (GH), LB03002, versus daily GH in adults with GH deficiency. J Clin Endocrinol Metab 2006;91(8):2926-30
35. European Medicines Agency. Valtropin. European Public Assessment report: Scientific Discussion. 2007. Available from: http://www.ema.europa.eu/ema/index. jsp?curl=pages/medicines/human/medicines/000602/human-med-001125.jsp&mid= WC0b01ac058001d124 [Accessed 12 march 2012]
36. Food and Drug Administration. Drug Approval package. 2007. Available from: http://www.accessdata.fda.gov/drugsatfda-docs/nda/2007/021905-valtropin- toc.cfm [Accessed 12 March 2012]
37. Romer T, Saenger P, Peter F, et al. Seven years of safety and efficacy of the recombinant human growth hormone Omnitrope in the treatment of growth hormone deficient children: results of a phase III study. Horm Res 2009; 72(6):359-69
38. Stanhope R, Sorgel F, Gravel P, et al. Bioequivalence studies of omnitrope, the first biosimilar/rhGH follow-on protein: two comparative phase 1 randomized studies and population pharmacokinetic analysis. J Clin Pharmacol 2010; 50(11):1339-48
39. Fuhr U, Tuculanu D, Berghout A, et al. Bioequivalence between novel ready-to-use liquid formulations of the recombinant human GH Omnitrope and the original lyophilized formulations for reconstitution of Omnitrope and Genotropin. Eur J Endocrinol 2010; 162(6):1051-8
40. Farias J, Feleder E, Gonzalez E, et al. Relative bioavailability of two drug products of somatropin obtained from either the milk of transgenic cows or bacterial culture. Horm Res Paediatr 2010;73(4):258-64
41. Liedert B, Forssmann U, Wolna P, et al. Comparison of the pharmacokinetics, safety and tolerability of two concentrations of a new liquid recombinant human growth hormone formulation versus the freeze-dried formulation. BMC Clin Pharmacol 2010;10:14
42. Ullah A, Peacock H, Arutchelvam V, et al. The cost, efficacy and safety of Omnitrope compared with Genotropin in adults with growth hormone deficiency. Endocr Abstracts 2012;28:P52
43. Cheung WK, Natarajan J, Sanders M, Vercammen E. Comparative pharmacokinetics, safety, and tolerability after subcutaneous administration of recombinant human erythropoietin formulated with different stabilizers. Biopharm Drug Dispos 2000; 21(6):211-19
44. Bren A, Kandus A, Varl J, et al. A comparison between epoetin omega and epoetin alfa in the correction of anemia in hemodialysis patients: a prospective, controlled crossover study. Artif Organs 2002;26(2):91-7
45. Nissenson AR, Swan SK, Lindberg JS, et al. Randomized, controlled trial of darbepoetin alfa for the treatment of anemia in hemodialysis patients. Am J Kidney Dis 2002;40(1):110-18
46. Vanrenterghem Y, Barany P, Mann JF, et al. Randomized trial of darbepoetin alfa for treatment of renal anemia at a reduced dose frequency compared with rHuEPO in dialysis patients. Kidney Int 2002;62(6):2167-75
47. Locatelli F, Canaud B, Giacardy F, et al. Treatment of anaemia in dialysis patients with unit dosing of darbepoetin alfa at a reduced dose frequency relative to recombinant human erythropoietin (rHuEpo). Nephrol Dial Transplant 2003;18(2):362-9
48. Togawa A, Tanaka T, Nagashima S, et al. A comparison of the bioequivalence of two formulations of epoetin alfa after subcutaneous injection. Br J Clin Pharmacol 2004;58(3):269-76
49. Brunkhorst R, Bommer J, Braun J, et al. Darbepoetin alfa effectively maintains haemoglobin concentrations at extended dose intervals relative to intravenous or subcutaneous recombinant human erythropoietin in dialysis patients. Nephrol Dial Transplant 2004; 19(5):1224-30
50. Milutinovic S, Plavljanic E, Trkulja V. Comparison of two epoetin brands in anemic hemodialysis patients: results of two efficacy trials and a single-dose pharmacokinetic study. Fundam Clin Pharmacol 2006;20(5):493-502
51. Akizawa T, Koshikawa S, Iwasaki M; KRN321 A08 Study Group. Darbepoetin alfa effectively maintains hemoglobin concentrations at extended dose intervals relative to intravenous rHuEPO in Japanese dialysis patients. Ther Apher Dial 2007;11(3):220-6
52. Besarab A, Salifu MO, Lunde NM, et al. Efficacy and tolerability of intravenous continuous erythropoietin receptor activator: a 19-week, phase II, multicenter, randomized, open-label, dose-finding study with a 12-month extension phase in patients with chronic renal disease. Clin Ther 2007; 29(4):626-39
53. Klinger M, Arias M, Vargemezis V, et al. Efficacy of intravenous methoxy polyethylene glycol-epoetin beta administered every 2 weeks compared with epoetin administered 3 times weekly in patients treated by hemodialysis or peritoneal dialysis: a randomized trial. Am J Kidney Dis 2007;50(6):989-1000
54. Levin NW, Fishbane S, Canedo FV, et al. Intravenous methoxy polyethylene glycol-epoetin beta for haemoglobin control in patients with chronic kidney disease who are on dialysis: a randomised non-inferiority trial (MAXIMA). Lancet 2007;370(9596):1415-21
55. Smith WB, Dowell JA, Pratt RD. Pharmacokinetics and pharmacodynamics of epoetin delta in two studies in healthy volunteers and two studies in patients with chronic kidney disease. Clin Ther 2007;29(7):1368-80
56. Sulowicz W, Locatelli F, Ryckelynck JP, et al. Once-monthly subcutaneous C.E.R. A. maintains stable hemoglobin control in patients with chronic kidney disease on dialysis and converted directly from epoetin one to three times weekly. Clin J Am Soc Nephrol 2007;2(4):637-46
57. Hymes J, Bickimer T, Jackson JH, et al. Dosing patterns, drug costs, and hematologic outcome in anemic patients with chronic kidney disease switching from darbepoetin alfa to epoetin alfa. Curr Med Res Opin 2007;23(8):1931-7
58. Roger SD, Suranyi MG, Walker RG, et al. A randomised, cross-over study comparing injection site pain with subcutaneous epoetin beta and subcutaneous darbepoetin alfa in patients with chronic kidney disease. Curr Med Res Opin 2008;24(8):2181-7
59. Bock HA, Hirt-Minkowski P, Brunisholz M, et al. Darbepoetin alpha in lower-than-equimolar doses maintains haemoglobin levels in stable haemodialysis patients converting from epoetin alpha/beta. Nephrol Dial Transplant 2008;23(1):301-8
60. Li WY, Chu, TS Huang, et al. Randomized study of darbepoetin alfa and recombinant human erythropoietin for treatment of renal anemia in chronic renal failure patients receiving peritoneal dialysis. J Formos Med Assoc 2008;107(11):843-50
61. Wizemann V, Rutkowski B, Baldamus C, Epoetin Zeta Study Group. Comparison of the therapeutic effects of epoetin zeta to epoetin alfa in the maintenance phase of renal anaemia treatment. Curr Med Res Opin 2008;24(3):625-37
62. Hiramatsu M, Kubota M, Iwasaki M, KRN321 A09 Study Group. Darbepoetin alfa (KRN321) administered intravenously once monthly maintains hemoglobin levels in peritoneal dialysis patients. Ther Apher Dial 2008; 12(1):19-27
63. Canaud B, Mingardi G, Braun J, et al. Intravenous C.E.R.A. maintains stable haemoglobin levels in patients on dialysis previously treated with darbepoetin alfa: results from STRIATA, a randomized phase III study. Nephrol Dial Transplant 2008;23(11):3654-61
64. Hirai T, Sugiya N, Nakashima A, et al. Switching from epoetin alpha to darbepoetin alpha in Japanese hemodialysis patients: dose conversion ratio. Nephron Clin Pract 2009; 111(2):c81-6
65. Chazot C, Terrat JC, Dumoulin A, et al. Randomized equivalence study evaluating the possibility of switching hemodialysis patients receiving subcutaneous human erythropoietin directly to intravenous darbepoetin alfa. Ann Pharmacother 2009;43(2):228-34
66. Cho SH, Lim HS, Ghim JL, et al. Pharmacokinetic, tolerability, and bioequivalence comparison of three different intravenous formulations of recombinant human erythropoietin in healthy Korean adult male volunteers: an open-label, randomized-sequence, threetreatment, three-way crossover study. Clin Ther 2009;31(5):1046-53
67. Frei U, Kwan JT, Spinowitz BS. Epoetin Delta 3002 Study Group. Anaemia management with subcutaneous epoetin delta in patients with chronic kidney disease (predialysis, haemodialysis, peritoneal dialysis): results of an openlabel, 1-year study. BMC Nephrol 2009;10:5
68. Haag-Weber M, Vetter A, Thyroff-Friesinger U; INJ-Study Group. Therapeutic equivalence, long-term efficacy and safety of HX575 in the treatment of anemia in chronic renal failure patients receiving hemodialysis. Clin Nephrol 2009;72(5):380-90
69. Turner M, Hartmann U, Dellanna F. HX575 epoetin-alpha effectively maintains stable haemoglobin levels in patients on haemodialysis with symptomatic anaemia due to chronic renal failure. BANTAO Journal 2009; 7(s1):p32
70. Carrera F, Lok CE, de Francisco A, et al. Maintenance treatment of renal anaemia in haemodialysis patients with methoxy polyethylene glycol-epoetin beta versus darbepoetin alfa administered monthly: a randomized comparative trial. Nephrol Dial Transplant 2010;25(12):4009-17
71. Fliser D, Kleophas W, Dellanna F, et al. Evaluation of maintenance of stable haemoglobin levels in haemodialysis patients converting from epoetin or darbepoetin to monthly intravenous C.E. R.A.: the MIRACEL study. Curr Med Res Opin 2010;26(5):1083-9
72. Kim TE, Kim KP, Kim BH, et al. Pharmacokinetic and pharmacodynamic comparison of two recombinant human erythropoietin formulations after single subcutaneous administration: an open-label, sequence-randomized, two-treatment crossover study in healthy Korean male volunteers. Clin Ther 2010;32(11):1968-76
73. Minutolo R, Zamboli P, Chiodini P, et al. Conversion of darbepoetin to low doses of CERA maintains hemoglobin levels in non-dialysis chronic kidney disease patients. Blood Purif 2010;30(3):186-94
74. 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;27(2):105-17
75. Dellanna F, Winkler RE, Bozkurt F, et al. Dosing strategies for conversion of haemodialysis patients from short-acting erythropoiesis stimulating agents to once-monthly C.E.R.A.: experience from the MIRACEL study. Int J Clin Pract 2011;65(1):64-72
76. Ode M, Roth K, Locatelli F, Horl WH.Switch from a broad range of erythropoiesis stimulating agents to HX575 (biosimilar epoetin alfa): a 6-month prospective multicenter study. NDT Plus 2011;4(suppl 2):32
77. Sacco P, Patrone P, Ervo R, et al. Treatment of anaemia with HX575 (recombinant human epoetin alfa) in haemodialysis patients: Liguria's multi-centre experience. G Ital Nefrol 2011;28(S53):S76
78. Hoglund M, Smedmyr B, Bengtsson M, et al. Mobilization of CD34+ cells by glycosylated and nonglycosylated G-CSF in healthy volunteers-a comparative study. Eur J Haematol 1997;59(3):177-83
79. Bonig H, Silbermann S, Weller S, et al. Glycosylated vs non-glycosylated granulocyte colony-stimulating factor (G-CSF)-results of a prospective randomised monocentre study. Bone Marrow Transplant 2001;28(3):259-64
80. Carlsson G, Ahlin A, Dahllof G, et al. Efficacy and safety of two different rG-CSF preparations in the treatment of patients with severe congenital neutropenia. Br J Haematol 2004; 126(1):127-32
81. Lubenau H, Bias P, Maly AK, et al. Pharmacokinetic and pharmacodynamic profile of new biosimilar filgrastim XM02 equivalent to marketed filgrastim Neupogen: single-blind, randomized, crossover trial. BioDrugs 2009; 23(1):43-51
82. Lubenau H, Sveikata A, Gumbrevicius G, et al. Bioequivalence of two recombinant granulocyte colonystimulating factor products after subcutaneous injection in healthy volunteers. Int J Clin Pharmacol Ther 2009;47(4):275-82
83. Waller CF, Bronchud M, Mair S, Challand R. Comparison of the pharmacodynamic profiles of a biosimilar filgrastim and Amgen filgrastim: results from a randomized, phase I trial. Ann Hematol 2010;89(10):971-8
84. Gascon P. Evaluating erythropoietic agents for the treatment of anaemia in the oncology setting. Eur J Cancer 2005;41(17):2601-12