EMA response to ECCO position statement on biosimilars

Journal of Crohn's and Colitis

Volumn 8, Issue 3, 2014, Pages 259-

  Danese, Silvio ^a   Gomollon, Fernando ^a   Michetti, Pierre ^a  

^a NONE

Author keywords

[No Author keywords available]

Indexed keywords

BIOLOGICAL PRODUCTS; HUMANS; INFLAMMATORY BOWEL DISEASES;

EID: 84894232162     PISSN: 18739946     EISSN: 18764479     Source Type: Journal    
DOI: 10.1016/j.crohns.2014.01.017     Document Type: Letter

References (7)

1. Guideline on similar biological medicinal products. CHMP/437/04 Rev 1 Accessed at, [10-12-13]. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2013/05/WC500142978.pdf.
2. Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues EMA/CHMP/BWP/247713/2012 Rev 1 Accessed at, [10-12-13]. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/05/WC500127960.pdf.
3. Draft guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues. EMEA/CHMP/BMWP/42832/2005 Rev. 1 Accessed at, [10-12-13]. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2013/06/WC500144124.pdf.
4. Guideline on similar biological medicinal products containing monoclonal antibodies - non-clinical and clinical issues. EMA/CHMP/BMWP/403543/2010 Accessed at, [10-12-13]. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/06/WC500128686.pdf.
5. Guideline on immunogenicity assessment of monoclonal antibodies intended for in vivo clinical use. EMA/CHMP/BMWP/86289/2010 Accessed at, [10-12-13]. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/06/WC500128688.pdf.
6. Guideline on comparability of biotechnology-derived medicinal products after a change in the manufacturing process. Non-clinical and clinical issues. EMEA/CHMP/BMWP/101695/2006 Accessed at, [10-12-13]. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003935.pdf.
7. 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 2013, 72:1605-1612.