Biosimilars: In support of extrapolation of indications

Journal of Crohn's and Colitis

Volumn 8, Issue 5, 2014, Pages 431-435

  Ebbers, Hans C ^a  

^a UTRECHT UNIVERSITY   (Netherlands)

Author keywords

Authorization; Biosimilar; Extrapolation; Infliximab; Safety; Tumor necrosis factor alpha

Indexed keywords

AZATHIOPRINE; BIOSIMILAR AGENT; CERTOLIZUMAB PEGOL; ETANERCEPT; INFLIXIMAB; METHOTREXATE; PLACEBO; TUMOR NECROSIS FACTOR ALPHA INHIBITOR; GASTROINTESTINAL AGENT; MONOCLONAL ANTIBODY; TUMOR NECROSIS FACTOR ALPHA;

ANTIBODY DEPENDENT CELLULAR CYTOTOXICITY; ARTICLE; BIOLOGICAL THERAPY; CLINICAL PRACTICE; COMPARATIVE STUDY; COST CONTROL; HEALTH CARE; HUMAN; IMMUNOGENICITY; PATIENT CARE; PRIORITY JOURNAL; ANTAGONISTS AND INHIBITORS; ECONOMICS; EUROPE; EVIDENCE BASED MEDICINE; INFLAMMATORY BOWEL DISEASES; TREATMENT OUTCOME;

ANTIBODIES, MONOCLONAL; BIOSIMILAR PHARMACEUTICALS; EUROPE; EVIDENCE-BASED MEDICINE; GASTROINTESTINAL AGENTS; HUMANS; INFLAMMATORY BOWEL DISEASES; TREATMENT OUTCOME; TUMOR NECROSIS FACTOR-ALPHA;

EID: 84897377081     PISSN: 18739946     EISSN: 18764479     Source Type: Journal    
DOI: 10.1016/j.crohns.2014.02.007     Document Type: Article

References (20)

1. 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 2006, (Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003920.pdf [Accessed, July 26, 2012]).
2. Lee H. Is extrapolation of the safety and efficacy data in one indication to another appropriate for biosimilars?. AAPS J Oct 11 2013, 10.1208/s12248-013-9534-y.
3. European Medicines Agency Inflectra. European public assessment report Available from:, [Accessed 6 Dec 2013]. http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002778/human_med_001677.jsp&mid=WC0b01ac058001d124.
4. Argüelles-Arias F., Barreiro-de-Acosta M., Carballo F., Hinojosa J., Tejerina T. Joint position statement by "Sociedad Española de Patología Digestiva" (Spanish Society of Gastroenterology) and "Sociedad Española de Farmacología" (Spanish Society of Pharmacology) on biosimilar therapy for inflammatory bowel disease. Rev Esp Enferm Dig 2013, 105(1):37-43.
5. American College of Rheumatology Position statement: biosimilars Available from:, [Accessed 24 Sep 2013]. http://www.rheumatology.org/Practice/Clinical/Position/Position_Statements/.
6. Espinosa Morales R., DÃaz BorjÃ3n A., Barile Fabris L.A., Esquivel Valerio J.A., Medrano RamÃrez G., Arce Salinas C.A., et al. Biosimilar drugs in Mexico: position of the Mexican College of Rheumatology, 2012. Reumatol ClÃnica 2013, 09(02). [113,116; 116].
7. Danese S., Gomollon F. Governing Board and Operational Board of ECCO. ECCO position statement: the use of biosimilar medicines in the treatment of inflammatory bowel disease (IBD). J Crohns Colitis 2013, 7(7):586-589. [http://dx.doi.org/10.1016/j.crohns.2013.03.011]. 10.1016/j.crohns.2013.03.011.
8. Kay J., Smolen J.S. Biosimilars to treat inflammatory arthritis: the challenge of proving identity. Ann Rheum Dis 2013, 72(10):1589-1593. 10.1136/annrheumdis-2012-203198.
9. Park W., Hrycaj P., Jeka S., Kovalenko V., Lysenko G., Miranda P., et al. A randomised, double-blind, multicentre, parallel-group, prospective study comparing the pharmacokinetics, safety, and efficacy of CT-P13 and innovator infliximab in patients with ankylosing spondylitis: the PLANETAS study. Ann Rheum Dis Oct 1 2013, 72(10):1605-1612. 10.1136/annrheumdis-2012-203091.
10. Yoo D.H., Hrycaj P., Miranda P., Ramiterre E., Piotrowski M., Shevchuk S., et al. A randomised, double-blind, parallel-group study to demonstrate equivalence in efficacy and safety of CT-P13 compared with innovator infliximab when coadministered with methotrexate in patients with active rheumatoid arthritis: the PLANETRA study. Ann Rheum Dis Oct 1 2013, 72(10):1613-1620. [http://dx.doi.org/10.1136/annrheumdis-2012-203090]. 10.1136/annrheumdis-2012-203090.
11. Goetze A.M., Liu Y.D., Zhang Z., Shah B., Lee E., Bondarenko P.V., et al. High-mannose glycans on the Fc region of therapeutic IgG antibodies increase serum clearance in humans. Glycobiology 2011, 21(7):949-959. [http://dx.doi.org/10.1093/glycob/cwr027]. 10.1093/glycob/cwr027.
12. European Medicines Agency Guideline on similar biological medicinal products containing monoclonal antibodies-non-clinical and clinical issues Available from:, [Accessed July 16, 2012]. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/06/WC500128686.pdf.
13. Vermeire S., Noman M., Van Assche G., Baert F., D'Haens G., Rutgeerts P. Effectiveness of concomitant immunosuppressive therapy in suppressing the formation of antibodies to infliximab in Crohn's disease. Gut 2007, 56(9):1226-1231. 10.1136/gut.2006.099978.
14. Maini R., St Clair E.W., Breedveld F., Furst D., Kalden J., Weisman M., et al. Infliximab (chimeric anti-tumour necrosis factor alpha monoclonal antibody) versus placebo in rheumatoid arthritis patients receiving concomitant methotrexate: a randomised phase III trial. ATTRACT Study Group. Lancet Dec 4 1999, 354(9194):1932-1939.
15. Reich K., Nestle F.O., Papp K., Ortonne J.P., Evans R., Guzzo C., et al. Infliximab induction and maintenance therapy for moderate-to-severe psoriasis: a phase III, multicentre, double-blind trial. Lancet Oct 15-21 2005, 366(9494):1367-1374. 10.1016/S0140-6736(05)67566-6.
16. Vultaggio A., Maggi E., Matucci A. Immediate adverse reactions to biologicals: from pathogenic mechanisms to prophylactic management. Curr Opin Allergy Clin Immunol 2011, 11(3):262-268. 10.1097/ACI.0b013e3283464bcd.
17. Steenholdt C., Palarasah Y., Bendtzen K., Teisner A., Brynskov J., Teisner B., et al. Pre-existing IgG antibodies cross-reacting with the Fab region of infliximab predict efficacy and safety of infliximab therapy in inflammatory bowel disease. Aliment Pharmacol Ther 2013, 37(12):1172-1183. [http://dx.doi.org/10.1111/apt.12330]. 10.1111/apt.12330.
18. Beck A., Wagner-Rousset E., Bussat M.C., Lokteff M., Klinguer-Hamour C., Haeuw J.F., et al. Trends in glycosylation, glycoanalysis and glycoengineering of therapeutic antibodies and Fc-fusion proteins. Curr Pharm Biotechnol 2008, 9(6):482-501.
19. Tracey D., Klareskog L., Sasso E.H., Salfeld J.G., Tak P.P. Tumor necrosis factor antagonist mechanisms of action: a comprehensive review. Pharmacol Ther 2008, 117(2):244-279. 10.1016/j.pharmthera.2007.10.001.
20. Shealy D., Cai A., Staquet K., Baker A., Lacy E.R., Johns L., et al. Characterization of golimumab, a human monoclonal antibody specific for human tumor necrosis factor alpha. mAbs Jul 8 2010, 2(4).