Biosimilar insulins

Expert Opinion on Biological Therapy

Volumn 12, Issue 8, 2012, Pages 1009-1016

  Heinemann, Lutz ^a  

^a Science and Co   (Germany)

Author keywords

biosimilar insulin; insulin analogs; insulin antibodies; insulin formulations; insulin glargine; insulin therapy

Indexed keywords

BIOSIMILAR AGENT; INSULIN; INSULIN ANTIBODY; INSULIN GLARGINE; RECOMBINANT ERYTHROPOIETIN;

DRUG ANTIGENICITY; DRUG COST; DRUG EFFICACY; DRUG FORMULATION; DRUG INDUSTRY; DRUG MANUFACTURE; DRUG MARKETING; DRUG SAFETY; EVIDENCE BASED MEDICINE; GOOD MANUFACTURING PRACTICE; HEALTH CARE QUALITY; HUMAN; IN VITRO STUDY; NONHUMAN; REVIEW; UNITED STATES;

ANIMALS; ANTIBODIES; BIOSIMILAR PHARMACEUTICALS; CHEMISTRY, PHARMACEUTICAL; DRUG APPROVAL; DRUG DESIGN; DRUG INDUSTRY; EUROPE; GUIDELINES AS TOPIC; HUMANS; HYPOGLYCEMIC AGENTS; INSULIN; PATIENT SAFETY; QUALITY CONTROL; RISK ASSESSMENT; RISK FACTORS; UNITED STATES;

EID: 84863803301     PISSN: 14712598     EISSN: None     Source Type: Journal    
DOI: 10.1517/14712598.2012.688024     Document Type: Review

References (22)

1. Sekhon BS, Saluja V. Biosimilars: An overview. Biosimilars 2011;1:1-11
2. Roger SD. Biosimilars: Current status and future directions. Expert Opin Biol Ther 2010;10:1011-18
3. Kresse GB. Biosimilars-science, status, and strategic perspective. Eur J Pharm Biopharm 2009;72:479-86
4. Weise M, Bielsky MC, De Smet K, et al. Biosimilar - why terminology matters. Nat Biotechnol 2011;29:690-3
5. Available from: Http://www.who.int/ biologicals/publications/trs/areas/ biological-therapeutics/BS2110Dft-guidelines-Final-HK-IK-29July-09.pdf
6. Kuhlmann M, Marre M. Lessons learned from biosimilar epoetins and insulins. Br J Diabetes Vasc Dis 2010;10:90-7
7. Heinemann L, Hompesch M. Biosimilar insulins: How similar is similar? J Diabetes Sci Technol 2011;5:741-54
8. Joshi SR. Biosimilar insulins: Are they really 'similar'? J Assoc Physicians India 2009;57(Suppl):38-41
9. Kramer I, Sauer T. The new world of biosimilars: What diabetologists need to know about biosimilar insulins. BrJ Diabetes Vasc Dis 2010;10:163-71
10. Zib I, Raskin P. Novel insulin analogues and its mitogenic potential. Diabetes Obes Metab 2006;8:611-20
11. Kannan V, Narayanaswamy P, Gadamsetty D, et al. A tandem mass spectrometric approach to the identification of O-glycosylated glargine glycoforms in active pharmaceutical ingredient expressed in Pichia pastoris. Rapid Commun Mass Spectrom 2009;23:1035-42
12. Schmidt A, et al. IDF 2011 Word Diabetes Congress Abstract Book (2011 International Diabetes Foundation), p. 466. Available from: Http://conference2. idf.org/dubai2011/CM.NET.WebUI/CM.NET.WEBUI.SCPR/SCPRfunctiondetail.aspx?confID= 05000000-0000-0000-0000-000000000001&sesID=05000000-0000-0000-0000- 000000000509&absID=07000000-0000-0000-0000-000000002456[Last accessed 19 January 2012]
13. 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
14. Kuhlmann M, Covic A. The protein science of biosimilars. Nephrol Dial Transplant 2006;21(Suppl 5):v4-8
15. Casadevall N, Eckardt KU, Rossert J. Epoetin-induced autoimmune pure red cell aplasia. J Am Soc Nephrol 2005;16:S67-9
16. Praditpornsilpa K, Tiranathanagul K, Kupatawintu P, et al. Biosimilar recombinant human erythropoietin induces the production of neutralizing antibodies. Kidney Int 2011;80:88-92
17. Schellekens H, Moors E. Clinical comparability and European biosimilar regulations. Nat Biotechnol 2010;28:28-31
18. Cheng SW, Lu J, Pan C, et al. Studies of pharmacokinetic, pharmacodynamic properties and bioequivalence of recombinant insulin glargine injection in healthy man. Chin J Diabetes 2010;18:387-93
19. Verma M, Hazra P, Iyer H, et al. Basalog- is similar to Lantus- in producing glycemic control in patients with type 1 diabetes mellitus on multiple daily insulin regimens. Int J Diabetes Dev Ctries 2011;31:26-31
20. Hazell L, Shakir SAW. Under-reporting of adverse drug reactions: A systematic review. Drug Safety 2006;29:385-96
21. Hasford J, Goettler M, Munter KH, Muller-Oerlinghausen B. Physicians' knowledge and attitudes regarding the spontaneous reporting system for adverse drug reactions. J Clin Epidemiol 2002;55:945-50
22. Available from: Http://www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatory Information/Guidances/UCM291128.pdf