New preparations comprising recombinant human growth hormone: Deliberations on the issue of biosimilars

Hormone Research

Volumn 69, Issue 1, 2007, Pages 22-28

  Ranke, Michael B ^a  

^a UNIVERSITY HOSPITAL TÜBINGEN   (Germany)

Author keywords

Biosimilars; Growth hormone; Growth promotion; Treatment, growth hormone deficiency

Indexed keywords

RECOMBINANT GROWTH HORMONE;

CHRONIC KIDNEY FAILURE; DRUG EFFICACY; DRUG SAFETY; GROWTH HORMONE DEFICIENCY; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HORMONE SUBSTITUTION; HUMAN; POLYACRYLAMIDE GEL ELECTROPHORESIS; PRADER WILLI SYNDROME; PREPUBERTY; PRIORITY JOURNAL; REVIEW; RIBOSOME; SMALL FOR DATE INFANT; TURNER SYNDROME;

BIOLOGICAL PRODUCTS; DRUG APPROVAL; EUROPEAN UNION; HUMAN GROWTH HORMONE; HUMANS; LEGISLATION, DRUG;

EID: 37249029798     PISSN: 03010163     EISSN: None     Source Type: Journal    
DOI: 10.1159/000111791     Document Type: Review

References (55)

1. Baumann G: Growth hormone heterogeneity: genes, isohormones, variants, and binding protein. Endocr Rev 1991;12:424-449.
2. Moseley CT, Phillips JA: Pituitary gene mutations and the growth hormone pathway. Semin Reprod Med 2000;18:21-29.
3. Smith RG, van der Ploeg LHT, Howard AD, Feighner SD, Cheng K, Hickey GJ, Wyvratt MJ, Fisher MH, Nargund RP, Patchett AA: Peptidomimetic regulation of growth hormone secretion. Endocr Rev 1997;18:621-645.
4. Kelly PA, Finidori J, Moulin S, Kedzia C, Binart N: Growth hormone receptor signalling and actions in bone growth. Horm Res 2001;55(suppl 1):14-17.
5. Ranke MB, Elmlinger M: Functional role of insulin-like growth factor binding proteins. Horm Res 1997;48(suppl 4):9-15.
6. Moeller N: The role of growth hormone in the regulation of human fuel metabolism; in Flyvbjerg A, Örskov H, Alberti KGMM (eds): Growth Hormone and Insulin-Like Growth Factor I. New York, Wiley, 1993, pp 77-108.
7. Jorgensen JO, Vestergaard E, Gormsen L, Jessen N, Norrelund H, Christiansen JS, Moeller N: Metabolic consequences of GH deficiency. J Endocrinol Invest 2005;28(suppl):47-51.
8. Zabransky S, Ranke MB: Wachstumshormon in der Pädiatrie: Aktuelle und zukünftige Behandlungskonzepte. Mannheim, Palatium, 2002.
9. Ranke MB: Growth hormone insufficiency: clinical features, diagnosis, and therapy; in DeGroot L (ed): Endocrinology, ed 3. Philadelphia, Saunders, 1994, pp 330-340.
10. Wüster C, von zur Mühlen A, Ranke MB: Das Syndrom des Wachstumshormonmangels beim Erwachsenen. Dtsch Ärzteblatt 1994;91:B1795-B1796.
11. Rosenfeld RG, Albertsson-Wikland K, Cassorla F, Fraizier SD, Hasegawa Y, Hintz RL, Lafranchi S, Lippe B, Loriaux L, Melmed S, Preece MA, Ranke MB, Reiter EO, Rogol AD, Underwood LE, Werther GA: Diagnostic controversy: the diagnosis of childhood growth hormone deficiency revisited. J Clin Endocrinol Metab 1995;80:1532-1540.
12. Thorner MO, Bengtsson BA, Ho KY, Albertsson-Wikland K, Christiansen JS, Faglia G, Irie M, Jörgensen JOL, Ranke M, Rosenfeld R, Shalet S, Takano K, van der Veen EA, Weissberger A: The diagnosis of growth hormone deficiency in adults. J Clin Endocrinol Metab 1995;80:3097-3098.
13. MB Ranke (ed): Diagnostics of Endocrine Function in Children and Adolescents, ed 3. Basel, Karger, 2003.
14. de Boer H, van der Veen E: Guidelines for optimizing growth hormone replacement therapy in adults. Horm Res 1997;48(suppl 5):21-30.
15. Thorner MO: Critical evaluation of the safety of recombinant human growth hormone administration: statement from the Growth Hormone Research Society. J Clin Endocrinol Metab 2001;86:1868-1870.
16. Bowlby DA, Rapaport R: Safety and efficacy of growth hormone therapy in childhood. Pediatr Endocrinol Rev 2004;2(suppl 1):68-71.
17. Cutfield WS, Wilton P, Bennmarker H, Albertsson-Wikland K, Chatelain P, Ranke MB, Price DA: Incidence of diabetes mellitus and impaired glucose tolerance in children and adolescents receiving growth hormone treatment. Lancet 2000;355:610-613.
18. Tattersall R: A history of growth hormone. Horm Res 1996;46:236-247.
19. Lindholm J: Growth hormone: historical notes. Pituitary 2006;9:5-10.
20. Raben MS: Treatment of a pituitary dwarf with human growth hormone. J Clin Endocrinol Metab 1958;18:901-903.
21. Hunter WM, Greenwood FC: Preparation of iodine-131 labelled human growth hormone of high specific activity. Nature 1962;194:495-496.
22. Stein J, Lester J, Fosten A, Shownkeen RC, Hartree AS: Studies of a human growth hormone preparation used for clinical treatment in Great Britain. J Endocrinol 1982;94:203-210.
23. Holmström B, Fhölenhag K: Characterization of human growth hormone preparations used for the treatment of pituitary dwarfism: a comparison of currently used batches. J Clin Endocrinol Metab 1975;40:856-862.
24. Bristow AF: International standards for growth hormone. Horm Res 1999;51(suppl):7-12.
25. Raiti S: The national hormone and pituitary program;in Raiti S, Tolman RA (eds): Human Growth Hormone. London, Plenum Press, 1986, pp 1-12.
26. Trygstad O, Voss I: Preparation of purified human growth hormone and a crude human pituitary gonadotropin. Acta Endocrinol (Copenh) 1971;66:478-490.
27. Jones RL, Benker G, Salacinski PR, Lloyd TJ, Lowry PJ: Large-scale preparation of highly purified pyrogen-free human growth hormone for clinical use. J Endocrinol 1979;82:77-86.
28. Powell-Jackson J, Weller RO, Kennedy P, Preece MA, Whitcombe EM, Newsom-Davis J: Creutzfeldt-Jacob disease after administration of human growth hormone. Lancet 1985;2:244-246.
29. Frazier SD: The not-so-good old days: working with pituitary growth hormone in North America, 1956 to 1985. J Pediatr 1997;131:1-4.
30. Goujard J, Entat M, Maillard F, Mugnier E, Rappaport R, Job JC: Evaluation of risks related to human growth hormone (hGH) treatment. Results of an epidemiologic survey conducted in France of patients treated from 1959 to 1985. Arch Fr Pediatr 1989;46:411-416.
31. Swerdlow AJ, Higgins CD, Adlard P, Jones ME, Preece MA: Creutzfeldt-Jacob disease in United Kingdom patients treated with human pituitary growth hormone. Neurology 2003;61:783-791.
32. Goeddel DV, Heyneker HL, Hozumi T, Arentzen R, Itakura K, Yansura DG, Ross MJ, Miozzari G, Crea R, Seeburg PH: Direct expression in Escherichia coli of a DNA sequence coding for human growth hormone. Nature 1979;281:544-548.
33. Flodh H: Human growth hormone produced with recombinant DNA technology: development and production. Acta Paediatr Scand 1986;325(suppl):1-9.
34. Ross MJ, Olson KC, Geier MD, O'Connor JV, Jones JS: Recombinant DNA synthesis of human growth hormone;in Raiti S, Tolman RA (eds): Human Growth Hormone. London, Plenum Press, 1986, pp 241-256.
35. Hizuka N, Hendricks CM, Pavlakis GN, Hamer DH, Gorden P: Properties of human growth hormone polypeptides: purified from pituitary extracts and synthesized in monkey kidney cells and bacteria. J Clin Endocrinol Metab 1982;55:545-550.
36. Catzel D, Lavelski H, Marquis CP, Gray PP, Van Dyk D, Mahler SM: Purification of recombinant human growth hormone from CHO cell culture supernatant by Gradiflow preparative electrophoresis technology. Protein Expr Purif 2003;32:126-134.
37. Gellerfors P, Eketorp G, Fhölenmhag K, Pavlu B, Johansson S, Fryklund L: Characterisation of a secreted form of recombinant derived human growth hormone, expressed in Escherichia coli cells. J Pharm Biomed Anal 1989;7:173-183.
38. Ribela MT, Gout PW, Bartolini P: Synthesis and chromatographic purification of recombinant human pituitary hormone. J Chromatogr B Analyt Technol Biomed Life Sci 2003;760:285-316.
39. Crommelin DJA: Differences between bio-pharmaceuticals and low-molecular-weight pharmaceuticals. Eur J Hosp Pharmacy 2003;1:74-76.
40. De Palo EF, Gatti R, Antonelli G, Spinella P: Growth hormone isoforms, segments/fragments: does a link exist with multifunctionality? Clin Chim Acta 2006;364:77-81.
41. Frost H: Antibody-mediated side effects of recombinant proteins. Toxicology 2005;209:155-160.
42. Fryklund LM, Bierich JR, Ranke MB: Recombinant human growth hormone. Clin Endocrinol Metab 1986;15:511-535.
43. Bierich JR, Ranke MB, Beyer P, Bittner P, Borkenstein H, Brämswig J, Butenandt O, Kollmann F, Stöver B, Schweikert HU: Therapie des hypophysären Zwergwuchses mit rekombinantem menschlichen Wachstumshormon. Eine Multizenterstudie. Dtsch Med Wochenschr 1986;111:483-489.
44. European Medicines Agency, Committee for Medicinal Products for Human Use (CHMP): Concept Paper on Guideline on Immunogenicity Assessment of Therapeutic Proteins. www.emea.eu.int/pdfs/human/biosimilar/24651105en.pdf
45. Blethen SL, Allen DB, Graves D, August G, Moshang T, Rosenfeld R: Safety of recombinant deoxyribonucleic acid-derived growth hormone: the National Cooperative Growth Study experience. J Clin Endocrinol Metab 1996;81:1704-1710.
46. Wilton P: Adverse events during GH treatment: 10 years' experience in KIGS; in Ranke MB, Wilton P (eds): Growth Hormone Therapy in KIGS - 10 Years Experience. Heidelberg, Barth, 1999, pp 349-364.
47. Wyatt D: Lessons from the national cooperative growth study. Eur J Endocrinol 2004;151(suppl 1):55-59.
48. Kemp SF, Kuntze J, Attie KM, Maneatis T, Butler S, Frane J, Lippe B: Efficacy and safety results of long-term growth hormone treatment of idiopathic short stature. J Clin Endocrinol Metab 2005;90:5502-5504.
49. European Medicines Agency, Committee for Medicinal Products for Human Use (CHMP): Concept Paper on Guideline on Comparability of Biotechnology derived Medicinal Products after a Change in the Manufacturing Process: Non-clinical and Clinical Issues. EMEA/CHMP/BMWP/9437/2006/corr
50. Omnitrope - European Public Assessment Report (EPAR): H/C/607. www.emea.eu. int/humandocs/PDFs/EPAR/Omnitrope/060706en1.pdf
51. Lu AY: Drug-metabolism research challenges in the new millennium: individual variability in drug therapy and drug safety. Drug Metab Dispos 1998;26:1217-1222.
52. Van Rijkom, Leufkens H, Crommelin D, Rutter F, Broekmens A: Assessment of biotechnology drugs: what are the issues. Health Policy 1999;47:255-274.
53. Ronco C: Biosimilars: how similar are they? Int J Artif Organs 2005;28:552-553.
54. Combe C, Tredree RL, Schellekens H: Biosimilar epoetins: an analysis based on recently implemented European medicines evaluation agency guidelines on comparability of biopharmaceutical proteins. Pharmacotherapy 2005;25:954-962.
55. Crommelin DJA, Bermejo T, Bissig M, Damiaans J, Krämer I, Rambourg P, Sctoccaro G, Strukelj B, Tredree R: Pharmaceutical evaluation of biosimilars: important differences from generic low-molecular-weight pharmaceuticals. Eur J Hosp Pharm Sci 2005;11:11-17.