Development of biosimilars-Pharmacokinetic and pharmacodynamic considerations

Journal of Biopharmaceutical Statistics

Volumn 20, Issue 1, 2010, Pages 46-61

  Wang, Yow Ming C ^a   Chow, Andrew T ^a  

^a AMGEN INC   (United States)

Author keywords

Biosimilars; Pharmacokinetics and pharmacodynamics; Similarity assessment; Therapeutic proteins

Indexed keywords

ABSEAMED; ADALIMUMAB; ALEFACEPT; ASPARAGINASE MACROGOL; BEVACIZUMAB; BIOGRASTIM; CONTINUOUS ERYTHROPOIESIS RECEPTOR ACTIVATOR; EFALIZUMAB; ETANERCEPT; HUMAN GROWTH HORMONE; HUMAN INSULIN; HYBRID PROTEIN; INFLIXIMAB; MONOCLONAL ANTIBODY; NOVEL ERYTHROPOIESIS STIMULATING PROTEIN; OKT 3; OMALIZUMAB; PANITUMUMAB; PEGINTERFERON ALPHA2A; PEGVISOMANT; RATIOGRASTIM; RECOMBINANT ERYTHROPOIETIN; RECOMBINANT GRANULOCYTE COLONY STIMULATING FACTOR; RECOMBINANT HUMAN INSULIN; RECOMBINANT PROTEIN; RITUXIMAB; ROMIPLOSTIM; SILOPA; TEVAGRASTIM; TRASTUZUMAB; UNCLASSIFIED DRUG; ZARZIO;

AREA UNDER THE CURVE; BIOEQUIVALENCE; BIOTECHNOLOGY; CLINICAL TRIAL; DRUG ABSORPTION; DRUG DISPOSITION; DRUG DISTRIBUTION; DRUG ELIMINATION; DRUG HALF LIFE; DRUG MECHANISM; DRUG TARGETING; HUMAN; MAXIMUM PLASMA CONCENTRATION; PHARMACODYNAMICS; PRACTICE GUIDELINE; PRIORITY JOURNAL; REVIEW;

ANIMALS; BIOLOGICAL PRODUCTS; BIOMEDICAL TECHNOLOGY; HUMANS; TECHNOLOGY, PHARMACEUTICAL;

EID: 75649135221     PISSN: 10543406     EISSN: 15205711     Source Type: Journal    
DOI: 10.1080/10543400903280357     Document Type: Review

References (60)

1. Baker, K., Qiao, S., W., Kuo, T., Kobayashi, K., Yoshida, M., Lencer, W. I., Blumberg, R. S. (2009). Immune and non-immune functions of the (not so) neonatal Fc receptor, FcRn. Semin. Immunopathol. 31:223-236.
2. Broudy, V. C., Lin, N. L. (2004). AMG531 stimulates megakaryopoiesis in vitro by binding to Mpl. Cytokine 25:52-60.
3. Egrie, J. C., Dwyer, E., Browne, J. K., Hitz, A., Lykos, M. A. (2003). Darbepoetin alfa has a longer circulating half-life and greater in vivo potency than recombinant human erythropoietin. Exp. Hematol. 31:290-299.
4. Elliott, S., Pham, E., Macdougall, I. C. (2008). Erythropoietins: a common mechanism of action. Exp. Hematol. 36:1573-1584.
5. EMEA. (2006a). Guideline on Similar Biological Medicinal Products Containing Biotechnology-Derived Proteins as Active Substance: Non-Clinical and Clinical Issues (CHMP/42832/05).
6. EMEA. (2006b). Annex to Guideline on Similar Biological Medicinal Products Containing Biotechnology-Derived Proteins as Active Substance: Non-Clinical and Clinical Issues-Guidance on Similar Medicinal Products Containing Recombinant Erythropoietins (CHMP/94526/05).
7. EMEA. (2006c). Annex to Guideline on Similar Biological Medicinal Products Containing Biotechnology-Derived Proteins as Active Substance: Non-Clinical and Clinical Issues-Guidance on Biosimilar Medicinal Products Containing Recombinant Granulocyte-Colony Stimulating Factor (CHMP/31329/05).
8. EMEA. (2006d). Annex to Guideline on Similar Biological Medicinal Products Containing Biotechnology-Derived Proteins as Active Substance: Non-Clinical and Clinical Issues-Guidance on Similar Medicinal Products containing Somatropin (CHMP/94528/05).
9. EMEA. (2006e). Annex to Guideline on Similar Biological Medicinal Products Containing Biotechnology-Derived Proteins as Active Substance: Non-Clinical and Clinical Issues-Guidance on Similar Medicinal Products Containing Recombinant Human Insulin (CHMP/32775/05).
10. EMEA. (2007). Draft Guideline for Similar Medicinal Products Containing Recombinant Interferon Alpha (CHMP/BMWP/102046/06).
11. Ghezzi, P., Cerami, A. (2005). Tumor necrosis factor as a pharmacological target. Mol. Biotechnol. 31:239-244.
12. Gibiansky, L., Gibiansky, E., Kakkar, T., Ma, P. (2008). Approximations of the target-mediated drug disposition model and identifiability of model parameters. J. Pharmacokinet. Pharmacodyn. 35:573-591.
13. Haffner, D., Schaefer, F., Girard, J., Ritz, E., Mehls, O. (1994). Metabolic clearance of recombinant human growth hormone in health and chronic renal failure. J. Clin. Invest. 93:1163-1171. (Pubitemid 24087171)
14. Hooks, M. A., Wade, C. S., Millikan, W. J., Jr. (1991). Muromonab CD-3: a review of its pharmacology, pharmacokinetics, and clinical use in transplantation. Pharmacotherapy 11:26-37.
15. Hudis, C. A. (2007). Trastuzumab-Mechanism of action and use in clinical practice. N. Engl. J. Med. 357:39-51.
16. Joung, J., Robertson, J. S., Griffiths, E., Knezevic, I. (2008). WHO informal consultation on regulatory evaluation of therapeutic biological medicinal products held at WHO Headquarters, Geneva, 19-20 April 2007. Biologicals 36:269-276.
17. Kimura, T., Kanzaki, Y., Matsumoto, Y., Mandai, M., Kurosaki, Y., Nakayama, T. (1994). Disposition of recombinant human insulin-like growth factor-I in normal and hypophysectomized rats. Biol. Pharm. Bull. 17:310-315.
18. Krzyzanski, W., Wyska, E. (2008). Pharmacokinetics and pharmacodynamics of erythropoietin receptor in healthy volunteers. Naunyn Schmiedebergs Arch. Pharmacol. 377:637-645.
19. Layton, J. E., Hockman, H., Sheridan, W. P., Morstyn, G. (1989). Evidence for a novel in vivo control mechanism of granulopoiesis: Mature cell-related control of a regulatory growth factor. Blood 74:1303-1307.
20. Lee, A., Whyte, M. K., Haslett, C. (1993). Inhibition of apoptosis and prolongation of neutrophil functional longevity by inflammatory mediators. J. Leukocyte Biol. 54:283-288.
21. Levy, G., Mager, D. E., Cheung, W. K., Jusko, W. J. (2003). Comparative pharmacokinetics of coumarin anticoagulants L: Physiologic modeling of S-warfarin in rats and pharmacologic target-mediated warfarin disposition in man. J. Pharm. Sci. 92:985-994.
22. Li, J., Xia, Y., Kuter, D. J. (1999). Interaction of thrombopoietin with the platelet c-mpl receptor in plasma: Binding, internalization, stability and pharmacokinetics. Br. J. Haematol. 106:345-356.
23. Lobo, E. D., Hansen, R. J., Balthasar, J. P. (2004). Antibody pharmacokinetics and pharmacodynamics. J. Pharm. Sci. 93:2645-2668.
24. Mager, D. E. (2006). Target-mediated drug disposition and dynamics. Biochem. Pharmacol. 72:1-10.
25. Mager, D. E., Jusko, W. J. (2001). General pharmacokinetic model for drugs exhibiting target-mediated drug disposition. J. Pharmacokinet. Pharmacodyn. 28:507-532.
26. Meijer, R. T., Koopmans, R. P., Ten Berge, I. J., Schellekens, P. T. (2002). Pharmacokinetics of murine anti-human CD3 antibodies in man are determined by the disappearance of target antigen. J. Pharmacol. Exp. Ther. 300:346-353.
27. Miller, K. J., Bowsher, R. R., Celniker, A., Gibbons, J., Gupta, S., Lee, J. W., Swanson, S. J., Smith, W. C., Weiner, R. S. (2001). Workshop on bioanalytical methods validation for macromolecules: summary report. Pharm. Res. 18:1373-1383.
28. Park, S. S., Park, J., Ko, J., Chen, L., Meriage, D., Crouse-Zeineddini, J., Wong, W., Kerwin, B. A. (2009). Biochemical assessment of erythropoietin products from Asia versus US Epoetin alfa manufactured by Amgen. Journal of Pharmaceutical Sciences 98:1688-1699.
29. Perez-Oliva, J. F., Casanova-Gonzalez, M., Garcia-Garcia, I., Porrero-Martin, P. J., Valenzuela-Silva, C. M., Hernandez-Montero, T., Lagarde-Ampudia, M., Casanova-Kutsareva, Y., Avila-Albuerne, Y., Vargas-Batista, A., Bobillo-Lopez, H., Herrera-Valdes, R., Lopez-Saura, P. A. (2005). Comparison of two recombinant erythropoietin formulations in patients with anemia due to end-stage renal disease on hemodialysis: a parallel, randomized, double blind study. BMC Nephrol. 6:5.
30. Prescribing information for Amevive™ (Alefacept). (March 2009). http://www.accessdata. fda.gov/drugsatfds-docs/label/2009/125036s100lbl.pdf
31. Prescribing information for Aranesp™ (Darbepoetin alfa). (November 2008). http://www. accessdata.fda.gov/drugsatfds-docs/label/2008/103951s5195PI. pdf
32. Prescribing information for Avastin™ (Bevacizumab). (July 2009). http://www.accessdata. fda.gov/drugsatfds-docs/label/2009/125085s0168lbl.pdf
33. Prescribing information for Enbrel™ (Etanercept). (June 2008). http://www.accessdata. fda.gov/drugsatfds-docs/label/2008/103795s5359lbl.pdf
34. Prescribing information for Epogen™/Procrit™ (Epoetin alfa). (March 2008). http://www. accessdata.fda.gov/drugsatfds-docs/label/2008/ 103234s5164lbl.pdf
35. Prescribing information for Herceptin™ (Trastuzumab). (January 2008). http://www. accessdata.fda.gov/drugsatfds-docs/label/2008/103792s5175lbl. pdf
36. Prescribing information for Humira™ (Adalimumab). (February 2008). http://www. accessdata.fda.gov/drugsatfds-docs/label/2008/125057s1114lbl.pdf
37. Prescribing information for Humulin™ (Human Insulin [rDNA origin]). (March 2009). http://www.accessdata.fda.gov/drugsatfds-docs/label/2009/ 018781s108,020563s091, 021017s053,021018s049lbl.pdf.
38. Prescribing information for Mircera™ (Methoxy polyethylene glycol). (November 2007). http://www.accessdata.fda.gov/drugsatfds-docs/label/2007/ 125164lbl.pdf
39. Prescribing information for Neulasta™ (Pegfilgrastim). (July 2007). http://www.accessdata. fda.gov/drugsatfds-docs/label/2007/125031s082lbl.pdf
40. Prescribing information for Neupogen™ (Filgrastim). (October 2006). http://www. accessdata.fda.gov/drugsatfds-docs/label/2006/103353s5086lbl.pdf
41. Prescribing information for Nplate™ (Romiplstim). (August 2008). http://www.accessdata. fda.gov/drugsatfds-docs/label/2009/125268s0026lbl.pdf
42. Prescribing information for Nutropin AQ™ (Somatropin [rDNA origin] injection). (October 2004). http://www.accessdata.fda.gov/drugsatfds-docs/label/ 2008/020522s026s036s 037lbl.pdf
43. Prescribing information for Oncaspar™ (Pegaspargase). (July 2006). http://www.accessdata. fda.gov/drugsatfds-docs/label/2006/103411s5052lbl.pdf
44. Prescribing information for Pegasys™ (Peginterferon alfa 2a). (April 2009). http://www. accessdata.fda.gov/drugsatfds-docs/label/2009/ 103964s5147,%20103964s5163lbl.pdf
45. Prescribing information for Raptiva™ (Efalizumab). (March 2009). http://www.accessdata. fda.gov/drugsatfds-docs/label/2009/125075s1301lbl.pdf
46. Prescribing information for Remicade™ (Infliximab). (April 2009). http://www.accessdata. fda.gov/drugsatfds-docs/label/2009/103772s5234lbl.pdf
47. Prescribing information for Rituxan™ (Rituximab). (September 2008). http://www. accessdata.fda.gov/drugsatfds-docs/label/2009/103705s5299lbl.pdf
48. Prescribing information for Somavert™ (Pegvisomant). (August 2008). http://www. accessdata.fda.gov/drugsatfds-docs/label/2008/021106s015lbl.pdf
49. Prescribing information for Vectibix™ (Panitumumab). (February 2009). http://www. accessdata.fda.gov/drugsatfds-docs/label/2009/125147s080lbl. pdf
50. Prescribing information for Xolair™ (Omalizumab). (July 2007). http://www.accessdata. fda.gov/drugsatfds-docs/label/2007/103976s5102lbl.pdf
51. Prescribing information of Genotropin™ (Somatropin [rDNA origin] injection). (May 2008). http://www.accessdata.fda.gov/drugsatfda-docs/label/ 2009/020280s064lbl.pdf
52. Presta, L. G. (2008). Molecular engineering and design of therapeutic antibodies. Curr. Opin. Immunol. 20:460-470.
53. Roskos, L. K., Lum, P., Lockbaum, P., Schwab, G., Yang, B. B. (2006). Pharmacokinetic/ pharmacodynamic modeling of pegfilgrastim in healthy subjects. Journal of Clinical Pharmacology 46:747-757.
54. Saltz, L., Easley, C., Kirkpatrick, P. (2006). Panitumumab. Nat. Rev. Drug Discov. 5:987-988.
55. Sarkar, C. A., Lauffenburger, D. A. (2003). Cell-level pharmacokinetic model of granulocyte colony-stimulating factor: implications for ligand lifetime and potency in vivo. Mol. Pharmacol. 63:147-158.
56. Schaefer, F., Baumann, G., Haffner, D., Faunt, L. M., Johnson, M. L., Mercado, M., Ritz, E., Mehls, O., Veldhuis, J. D. (1996). Multifactorial control of the elimination kinetics of unbound (free) growth hormone (GH) in the human: regulation by age, adiposity, renal function, and steady state concentrations of GH in plasma. J. Clin. Endocrinol. Metab. 81:22-31.
57. Waldmann, T. A., Strober, W. (1969). Metabolism of immunoglobulins. Prog. Allergy 13:1-110.
58. Wang, B., Ludden, T. M., Cheung, E. N., Schwab, G. G., Roskos, L. K. (2001). Population pharmacokinetic-pharmacodynamic modeling of filgrastim (r-metHuGCSF) in healthy volunteers. J. Pharmacokinet. Pharmacodyn. 28:321-342.
59. Wang, Y., Perez-Ruixo, J. J., Xiao, J., Doshi, S., Jaramilla, B., Chow, A., Krzyzanski, W. (2008). Pharmacokinetic and pharmacodynamic (PKPD) modeling of romiplostim, a novel thrombopoietic Fc-peptide fusion protein, in healthy subjects: a semimechanistic approach. Experimental Hematology 36(suppl. 1):S53.
60. Yang, B. B., Lum, P. K., Hayashi, M. M., Roskos, L. K. (2004). Polyethylene glycol modification of filgrastim results in decreased renal clearance of the protein in rats. Journal of Pharmaceutical Sciences 93:1367-1373.