Evolution of biologicals in inflammation medicine - Biosimilars in gastroenterology, rheumatology and dermatology;Evolution der Biologika in der Entzündungsmedizin - Biosimilars in Gastroenterologie, Rheumatologie und Dermatologie

Deutsche Medizinische Wochenschrift

Volumn 139, Issue 47, 2014, Pages 2399-2404

  Schreiber, S ^a   Luger, T ^b   Mittendorf, T ^c   Mrowietz, U ^a   Muller Ladner U ^d   Schroder J ^a   Stallmach, A ^e   Bokemeyer, B ^a,f  

^a UNIVERSITY HOSPITAL SCHLESWIG HOLSTEIN   (Germany)

^b UNIVERSITY HOSPITAL MÜNSTER   (Germany)

^c Herescon GmbH   (Germany)

^d KERCKHOFF HEART CENTER   (Germany)

^e JENA UNIVERSITY HOSPITAL   (Germany)

^f KLINIKUM MINDEN   (Germany)

Author keywords

anti TNF antibody; biosimilar; EMA; inflammation medicine; infliximab

Indexed keywords

BIOSIMILAR AGENT; BIOLOGICAL PRODUCT; CT-P13; INFLIXIMAB; MONOCLONAL ANTIBODY; TNF PROTEIN, HUMAN; TUMOR NECROSIS FACTOR ALPHA;

DERMATOLOGY; EVOLUTION; GASTROENTEROLOGY; INFLAMMATION; REVIEW; RHEUMATOLOGY; ANTAGONISTS AND INHIBITORS; ARTHRITIS, RHEUMATOID; COST CONTROL; DRUG APPROVAL; ECONOMICS; EUROPEAN UNION; GASTROINTESTINAL DISEASES; GERMANY; HUMAN; IMMUNOLOGY; PATENT; PUBLIC HEALTH; RHEUMATIC DISEASES; SKIN DISEASES; THERAPEUTIC EQUIVALENCE;

ANTIBODIES, MONOCLONAL; ARTHRITIS, RHEUMATOID; BIOLOGICAL PRODUCTS; BIOSIMILAR PHARMACEUTICALS; COST SAVINGS; DRUG APPROVAL; EUROPEAN UNION; GASTROINTESTINAL DISEASES; GERMANY; HUMANS; INFLAMMATION; NATIONAL HEALTH PROGRAMS; PATENTS AS TOPIC; RHEUMATIC DISEASES; SKIN DISEASES; THERAPEUTIC EQUIVALENCY; TUMOR NECROSIS FACTOR-ALPHA;

EID: 84922391272     PISSN: 00120472     EISSN: 14394413     Source Type: Journal    
DOI: 10.1055/s-0034-1387371     Document Type: Review

References (27)

1. Aringer M., Dörner T. Biosimilars. Current state of the build up to series production. Z Rheumatol: 2013; 72 873 877
2. Beaugerie L., Brousse N., Bouvier A. M. et al. Lymphoproliferative disorders in patient receiving thiopurines for inflammatory bowel disease: a prospective observational cohort study. Lancet: 2009; 374 1617 1625
3. Brandse J. F., Wildenberg M., de Bruyn J. R. et al. Fecal Loss of Infliximab as a Cause of Lack of Response in Severe Inflammatory Bowel Disease. Gastroenterology: 2013; 144 01 S36
4. Brekke K. R., Dalen D. M., Holmås T. H. Diffusion of Pharmaceuticals: Cross-Country Evidence of Anti-TNF drugs. Eur J Health Econ: 2013; [Epub ahead of print]
5. Dörner T., Strand V., Castañeda-Hernández G. et al. The role of biosimilars in the treatment of rheumatic disease. Ann Rheum Dis: 2013; 72 322 328
6. European Medicines Agency Inïectra Initial MAA - Summary of opinion. 06 2013; www.ema.europa.eu/docs/en-GB/document-library/Summary-of-opinion--Initial-authorisation/human/002778/ WC500144831.pdf (letzter Zugriff: 01.10.2014)
7. European Medicines Agency. Guideline on Similar Biological Medicinal Products. 22.05.2013. www.ema.europa.eu/ema/pages/includes/document/open-document.jsp?webContentId=WC500142978 (letzter Zugriff: 20.10.2014)
8. European Medicines Agency Questions and answers on biosimilar medicines (similar biological medicinal products). 09 2012; http://www.ema.europa.eu/docs/en-GB/document-library/Medicine-QA/2009/12/WC500020062.pdf (letzter Zugriff: 01.10.2014)
9. Glaeske G., Schicktanz C. Barmer GEK Arzneimittelreport 2013. 06 2013; http://presse.barmer-gek.de/barmer/web/Portale/Presseportal/Subportal/Presseinformationen/Archiv/2013/130611-Arzneimittelreport/PDF-Arzneimittelreport-2013,property=Data.pdf (letzter Zugriff: 01.10.2014)
10. Häussler B., Höer A., Hempel E. Hrsg. Arzneimittel-Atlas 2012. Berlin, Heidelberg Springer: 2013
11. Hsieh C. R., Liu Y. M. Availability, health-care costs and utilization patterns of biologics in Taiwan. Value Health: 2012; 15 35 42
12. Karindervjit S. N., Cheifetz A. S., Moss A. C. Impact of Antibodies to Infliximab on Clinical Outcomes and Serum Infliximab Levels in Patients with Inflammatory Bowel Disease (IBD): A Meta-Analysis. Am J Gastroenterol: 2013; 108 40 47
13. Liang S., Dai J., Hou S. et al. Structural Basis for treating tumor necrosis factor (TNF)-associated diseases with the therapeutic antibody infliximab. J Biol Chem: 2013; 288 13799 13807
14. Lida S., Misaka H., Inoue M. et al. Nonfucosylated therapeutic IgG1 antibody can evade the inhibitory effect of serum immunoglobulin G on antibody-dependent cellular cytotoxicity through its high binding to FcgammaRIIIa. Clin Cancer Res: 2006; 12 2879 2887
15. Louis E. J., Watier H. E., Schreiber S. et al. Polymorphism in IgG Fc receptor gene FCGR3A and response to infliximab in Crohn's disease: a subanalysis of the ACCENT I study. Pharmacogenet Genomics: 2006; 16 911 914
16. Miletich J., Eich G., Grampp G. et al. Biosimilars 2.0: guiding principles for a global patient first standard. MAbs: 2011; 3 318 325
17. Nature Medicine New Biologic drugs set to top 2012 sales. Nat Med: 2012; 1 636
18. 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 1612
19. Rahier J. F., Buche S., Peyrin-Biroulet L. et al. Severe skin lesions cause patients with inflammatory bowel disease to discontinue anti-tumor necrosis factor therapy. Clin Gastroenterol Hepatol: 2010; 8 1048 1055
20. Rinaudo-Gaujous M., Paul S., Tedesco E. D. et al. Review article: biosimilars are the next generation of drugs for liver and gastrointestinal diseases. Aliment Pharmacol Ther: 2013; 38 914 924
21. Schiestl M., Stangler T., Torella C. et al. Acceptable changes in quality attributes of glycosylated biopharmaceuticals. Nat Biotechnol: 2011; 29 310 122
22. Schwabe U., Paffrath D. Arzneiverordnungs-Report 2013. Berlin, Heidelberg Springer: 2013
23. Schuster M., Umana P., Ferrara C. et al. Improved effector functions of a therapeutic monoclonal Lewis Y-specific antibody by glycoform engineering. Cancer Res: 2005; 65 7934 7941
24. Tessensohn J. A., Yamamoto S. Patent term extension in biologic innovators in Japan. Nat Biotechnol: 2011; 29 34 37
25. US Food and Drug Administration Scientific considerations in demonstrating biosimilarity to a reference product. 02 2012; www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ UCM291128.pdf (letzter Zugriff: 01.10.2014)
26. Van Assche G., Vermeire S., Ballet V. et al. Switch to adalimumab in patients with Crohn's disease controlled by maintenance with infliximab: prospective randomized SWITCH trial. Gut: 2012; 61 229 234
27. Yoo D. H., 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 1620