SA JOURNAL OF DIABETES & VASCULAR DISEASE
REVIEW
VOLUME 8 NUMBER 1 • MARCH 2011
25
Acknowledgment
Editorial support for this article was provided by the medical writing
agency PHOCUS and by the sanofi-aventis group. The opinions
expressed in the current article are those of the authors. The
authors received no honoraria or other form of financial support
related to the development of this manuscript.
Declaration of conflict of interest
IK has been a consultant, speaker and member of advisory boards
of various (bio)pharmaceutical companies, which had no influence
on the content of this article. TS is an employee of sanofi-aventis
Deutschland GmbH.)
References
1.
European Medicines Agency. Press release: Marvel Life Sciences Ltd withdraws
its marketing authorisation applications for Insulin Human rapid Marvel, Insulin
Human Long Marvel and Insulin Human 30/70 Mix Marvel. 16 January 2008.
EMEA/2435/2008. London: EMA, 2008.
2.
Schellekens H. Follow-on biologics: challenges of the ‘next generation’.
Nephrol
Dial Transplant
2005;
20
(suppl 4): iv31–6.
3.
European Medicines Agency. Questions and Answers on biosimilar
medicines (similar biological medicinal products). 22 October 2008. Doc. Ref.
EMEA/74562/2006 rev.1. London: EMA, 2008.
/
pdfs/human/pcwp/7456206en.pdf.
4.
Schellekens H, Ryff JC. ‘Biogenerics’: the off-patent biotech products.
Trends
Pharmacol Sci
2002;
23
: 119–21.
5.
Locatelli F, roger S. Comparative testing and pharmacovigilance of biosimilars.
Nephrol Dial Transplant
2006;
21
(suppl 5): v13–16.
6.
Locatelli F, Del Vecchio L, Pozzoni P. Pure red-cell aplasia ‘epidemic’: mystery
completely revealed?
Perit Dial Int
2007;
27
(suppl 2): S303–07.
7.
Casadevall N, Nataf J, Viron B,
et al
. Pure red-cell aplasia and antierythropoietin
antibodies in patients treated with recombinant erythropoietin.
N Engl J Med
2002;
346
: 469–75.
8.
Schellekens H. Immunologic mechanisms of EPO-associated pure red cell aplasia.
Best Pract Res Clin Haematol
2005;
18
: 473–80.
9.
Kuhlmann M, Covic A. The protein science of biosimilars.
Nephrol Dial Transplant
2006;
21
(suppl 5): v4–8.
10. roger SD. Biosimilars: how similar or dissimilar are they?
Nephrology
2006;
11
:
341–6.
11. Mellstedt H, Niederwieser D. Ludwig H. The challenge of biosimilars.
Ann Oncol
2008;
19
: 411–9.
12. Grammer L. Insulin allergy.
Clin Rev Allergy
1986;
4
: 189–200.
13. Fineberg SE, Kaabata TT, Finco-Kent D,
et al
. Immunological responses to
exogenous insulin.
Endocrine Rev
2007;
28
: 625–52.
14. Joshi SR, Parikh RM, Das AK. Insulin: history, biochemistry, physiology and
pharmacology.
J Assoc Physicians India
2007;
55
(suppl): 19–25.
15. Sattley M. The history of diabetes.
Diabetes Health
2008.
diabeteshealth.com/read/2008/12/17/715/the-history-of-diabetes/(accessed 10
May 2009).
16. Teuscher A. The history of insulin. In: Insulin: A Voice for Choice. Basel:
Karger, 2007; 10–13.
/
isbn3_8055/_83/_53/Insulin_02.pdf (accessed 10 May 2009).
17. Neubauer RP, Lin HY, Mathiszik B. Metabolic load of recombinant protein
production: inhibition of cellular capacities for glucose uptake and respiration
after induction of a heterologous gene in
Escherichia coli. Biotechnol Bioeng
2003;
83
: 53–64.
18. Panda AK. Bioprocessing of therapeutic proteins from the inclusion bodies of
Escherichia coli. Adv Biochem Eng Biotechnol
2003;
85
: 43–93.
19. Winter J, Lilie H, rudolph r. renaturation of human proinsulin: a study on refolding
and conversion to insulin.
Anal Biochem
2002;
310
: 148–55.
20. Singh AM, Panda AK. Solubilization and refolding of bacterial inclusion body
proteins.
J Bioscience Bioeng
2005;
99
: 303–10.
21. Committee for Medicinal Products for Human Use. Annex 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. London: EMA, 2006.
.
europa.eu/pdfs/human/ biosimilar/3277505en.pdf (accessed 13 April 2009).
22. Beals JM, DeFilippis Mr, Kovach PM. Insulin. In: Crommelin DJA, Sindelar
RD, Meibohm B (eds.). Pharmaceutical Biotechnology: Fundamentals and
Applications, 3rd edn. Informa Healthcare: New York, 2008; 265–80.
23. European Medicines Agency. Guideline on the suitability of the graduation
of delivery devices for liquid dosage forms. Doc ref EMEA/CHMP/
QWP/178621/2004. London: EMA, 2004.
. eu/pdfs/
human/qwp/17862104en.pdf (accessed 10 May 2009).
24. International Organization for Standardization. Pen-injectors for medical use. Part
1: Pen-injectors. requirements and test methods (ISO 11608–1:2000). Geneva:
ISO, 2000.
25. Brunton S. Initiating insulin therapy in type 2 diabetes: benefits of insulin analogs
and insulin pens.
Diabetes Technol Ther
2008;
10
: 247–56.
26. Korytkowski M, Niskanen L, Asakura T. FlexPen: addressing issues of confidence
and convenience in insulin delivery.
Clin Ther
2005;
27
(suppl B): S89–100.
27. Korytkowski M, Bell D, Jacobsen C, Suwannasari r. FlexPen Study Team. A
multicenter, randomized, open-label, comparative, two-period crossover trial
of preference, efficacy, and safety profiles of a prefilled, disposable pen and
conventional vial/syringe for insulin injection in patients with type 1 or 2 diabetes
mellitus.
Clin Ther
2003;
25
: 2836–48.
28. Wiecek A, Mikhail A. European regulatory guidelines for biosimilars.
Nephrol Dial
Transplant
2006;
21
(suppl 5): v17–20.
29. Committee for Medicinal Products for Human Use. Guideline on similar biological
medicinal products. London: EMA, 2005.
. emea.europa.eu/pdfs/
human/biosimilar/043704en.pdf (accessed 13 April 2009).
30. Committee for Medicinal Products for Human Use. Guidelines on similar
biological medicinal products containing biotechnology-derived proteins as active
substance: quality issues. London: EMA, 2006 http://
/
human/biosimilar/4934805en.pdf (accessed 13 April 2009)
31. Committee for Medicinal Products for Human Use. Guideline on similar
biological medicinal products containing biotechnology-derived proteins as active
substance: non-clinical and clinical issues. London: EMA, 2006
.
europa.eu/pdfs/human/biosimilar/4283205en.pdf (accessed 13 April 2009)
32. European Medicines Agency. Pre-authorisation Evaluation of Medicines for
Human Use. Withdrawal Assessment report for Insulin Human rapid Marvel. 21
February 2008. Document reference EMEA/CHMP/317778/2007. London: EMA,
2008.
rvel/31777807en.pdf (accessed 1 May 2009)
33. European Medicines Agency. Pre-authorisation Evaluation of Medicines for
Human Use. Withdrawal Assessment report for Insulin Human Long Marvel. 21
February 2008. Document reference EMEA/CHMP/70349/2008. London: EMA:
2008.
rvel/7034908en.pdf (accessed 1 May 2009)
34. European Medicines Agency. Pre-authorisation Evaluation of Medicines for
Human Use. Withdrawal Assessment report for Insulin Human 30/70 Mixed
Marvel. 21 February 2008. Document reference EMEA/CHMP/70179/2008.
London: EMA: 2008.
humanrapidmarvel/701790en.pdf (accessed 1 May 2009)
35. Kuhlmann M, Marre M. Lessons learned from biosimilar epoetins and insulins.
Br
J Diabetes Vasc Dis
2010;
10
; 90–7.
36. Krämer I, Tredree R, Vulto AG. Points to consider in the evaluation of
biopharmaceuticals.
EJHP Practice
2008;
14
: 73–6.
37. Crommelin D, Bermejo T, Bissig M
et al
. Pharmaceutical evaluation of biosimilars:
important differences from generic low-molecular-weight pharmaceuticals.
Eur J
Hosp Pharm Sci
2005;
11
: 11–7.
