The rise of biosimilars: Potential benefits and drawbacks in rheumatoid arthritis

Expert Review of Clinical Immunology

Volumn 10, Issue 8, 2014, Pages 981-983

  Yoo, Dae Hyun ^a  

^a Hanyang University Hospital for Rheumatic Diseases   (South Korea)

Author keywords

Switching

Indexed keywords

BIOSIMILAR AGENT; CTP 13; DISEASE MODIFYING ANTIRHEUMATIC DRUG; INFLIXIMAB; MONOCLONAL ANTIBODY; UNCLASSIFIED DRUG; ANTIRHEUMATIC AGENT;

BIOLOGICAL THERAPY; GROSS NATIONAL PRODUCT; HUMAN; REVIEW; RHEUMATOID ARTHRITIS; ANIMAL; ARTHRITIS, RHEUMATOID; DRUG APPROVAL; DRUG SUBSTITUTION; ECONOMICS; FEE; HEALTH CARE DELIVERY;

ANIMALS; ANTIBODIES, MONOCLONAL; ANTIRHEUMATIC AGENTS; ARTHRITIS, RHEUMATOID; BIOSIMILAR PHARMACEUTICALS; DRUG APPROVAL; DRUG SUBSTITUTION; FEES, PHARMACEUTICAL; HEALTH SERVICES ACCESSIBILITY; HUMANS;

EID: 84904357521     PISSN: 1744666X     EISSN: 17448409     Source Type: Journal    
DOI: 10.1586/1744666X.2014.932690     Document Type: Review

References (22)

1. Nam JL, Ramiro S, Gaujoux-Viala C, et al. Efficacy of biological disease-modifying antirheumatic drugs: a systematic literature review informing the 2013 update of the EULAR recommendations for the management of rheumatoid arthritis. Rheum Dis 2014;73:516-28
2. Dörner T, Strand V, Castaneda-Hernandez G, et al. The role of biosimilars in the treatment of rheumatic diseases. Ann Rheum Dis 2013;72:322-8
3. Putrik P, Ramiro S, Kvien TK, et al. Inequities in access to biologic and synthetic DM.A.RDs across 46 European countries. Ann Rheum Dis 2014;73:198-206
4. Schneider CK. Biosimilars in rheumatology: the wind of change. Ann Rheum Dis 2013;72:315-18
5. Scheinberg M.A., Kay J. The advent of biosimilar therapies in rheumatology-"O Brave New World". Nat Rev Rheumatol 2012;8:430-6
6. Beck A, Reichert JM. Approval of the first biosimilar antibodies in Europe: a major landmark for the biopharmaceutical industry. M.A.bs 2013;5:621-3
7. Beck A, Wagner-Rousset E, Ayoub D, et al. Characterization of therapeutic antibodies and related products. Anal Chem 2013;85: 715-36
8. Beck A, Diemer H, Ayoub D, et al. Analytical characterization of biosimilar antibodies and Fc-fusion proteins. Trends Anal Chem 2013;48:81-95
9. Yoo DH, Hrycaj P, Miranda P, 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 2013;72:1613-20
10. Park W, Hrycaj P, Jeka S, 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 2013;72:1605-12
11. McKeage K. A review of CT P-13: infliximab biosimilar. BioDrugs 2014;28: 313-21
12. Maneiro J.R., Salgado E, Gomez-Reino JJ. Immunogenicity of monoclonal antibodies against tumor necrosis factor used in chronic immune-mediated inflammatory conditions. systematic review and meta-analysis. JAM.A. Intern Med 2013;173: 1416-28
13. Yoo DH. Efficacy and safety of CT-P13 (Infliximab biosimilar) over two years in patients with rheumatoid arthritis: comparison between continued CT-P13 and switching from Infliximab to CT-P13 (abstract no L1). ACR annual meeting; San Diego, CA, USA; 2013
14. Gecse KB, Khanna R, van den Brink GR, et al. Biosimilars in IBD: hope or expectation? Gut 2013;62:803-7
15. Ebbers HC, Muenzberg M, Schellekens H. The safety of switching between therapeutic proteins. Expert Opin Biol Ther 2012;12: 1473-85
16. Brodszky V, Baji P, Balogh O, Pentek M. Budget impact analysis of biosimilar infliximab (CT-P13) for the treatment of rheumatoid arthritis in six Central and Eastern European countries. Eur J Health Econ 2014;15(Suppl 1):65-71
17. Moreland LW, ODell J.R., Paulus HE, et al. A randomized comparative effectiveness study of oral triple therapy versus etanercept plus methotrexate in early aggressive rheumatoid arthritis: the treatment of early aggressive rheumatoid arthritis trial. Arthritis Rheum 2012;64:2824-35
18. Vollenhoven RFV, Geborek P, Forslind K, et al. Conventional combination treatment versus biological treatment in methotrexate-refractory early rheumatoid arthritis: 2 year follow-up of the randomised, non-blinded, parallel-group Swefot trial. Lancet 2012;379:1712-20
19. Schoels M, Wong J, Scott DL, et al. Economic aspects of treatment options in rheumatoid arthritis: a systematic literature review informing the EULAR recommendations for the management of rheumatoid arthritis. Ann Rheum Dis 2010;69:996-1004
20. Norways discount on infliximab: a litmus test for biosimilar expansion in Europe? Available from: http://healthcare.blogs.ihs.com/2014/03/20/norways- discount-oninfliximab-a-litmus-test-for-biosimilarexpansion-in-europe/
21. Biosimilar companies has marketing problem. Biosimilar news. 2014. Available from: www.biosimilarnews.com/tags/asbm
22. Editorial. The INN crowd. Nat Biotechnol 2013;31:1055