ECCO position statement: The use of biosimilar medicines in the treatment of inflammatory bowel disease (IBD)

Journal of Crohn's and Colitis

Volumn 7, Issue 7, 2013, Pages 586-589

  Danese, Silvio ^a   Gomollon, Fernando ^b  

^a HUMANITAS CLINICAL AND RESEARCH CENTER   (Italy)

^b INSTITUTO DE SALUD CARLOS III   (Spain)

Author keywords

Biosimilars; ; Inflammatory bowel disease;

Indexed keywords

BIOSIMILAR AGENT; INFLIXIMAB; TUMOR NECROSIS FACTOR ALPHA;

CROHN DISEASE; DRUG EFFICACY; DRUG SURVEILLANCE PROGRAM; HEALTH CARE COST; HUMAN; IMMUNOGENICITY; PRIORITY JOURNAL; REVIEW; SEPSIS; TUBERCULOSIS; ULCERATIVE COLITIS;

BIOLOGICAL AGENTS; BIOSIMILAR PHARMACEUTICALS; EUROPE; HUMANS; INFLAMMATORY BOWEL DISEASES;

EID: 84878624235     PISSN: 18739946     EISSN: 18764479     Source Type: Journal    
DOI: 10.1016/j.crohns.2013.03.011     Document Type: Review

References (10)

1. European Medicines Agency Questions and answers on biosimilar medicines (similar biological medicinal products). 2012 18 January 2013 Available from:. http://www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500020062.
2. EuropeanMedicines Agency Guideline on similar biological medicinal products. 2005 18 January 2013 Available from:. http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000408.jsp&mid=WC0b01ac058002958c.
3. European Medicines Agency Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substances: quality issues. 2012 18 January 2013 Available from:. http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000408.jsp&mid=WC0b01ac058002958c.
4. European Medicines Agency Human medicines - biosimilars. 2013 18 January 2013 Available from:. http://www.ema.europa.eu/ema/.
5. Biologic drugs set to top 2012 sales. Nat Med 2012, 18(5):636.
6. McCamish M., Woollett G. Worldwide experience with biosimilar development. MAbs 2011, 3(2):209-217.
7. Jelkmann W. Biosimilar epoetins and other ""follow-on" biologics: update on the European experiences. Am J Hematol 2010, 85(10):771-780.
8. Reichert J.M. Next generation and biosimilar monoclonal antibodies. Essential considerations towards regulatory acceptance in Europe. MAbs 2011, 3:223-240.
9. Miletich J., Eich G., Grampp G., Mounho B. Biosimilars 2.0. Guiding principles for a global "patients first" standard. MAbs 2011, 3:318-325.
10. Lee E.O., Emanuel E.J. Shared decision making to improve care and reduce costs. N Engl J Med 2013, 368:6-8.