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ECCO position statement on biosimilars

The updated ECCO position statement supports the use of biosimilar infliximab in appropriate patients with IBD5

“Switching from the originator to a biosimilar in patients with IBD is acceptable. Studies of switching can provide valuable evidence for safety and efficacy. Scientific and clinical evidence is lacking regarding reverse switching, multiple switching, and cross-switching among biosimilars in IBD patients”5

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“The initial observational data published on efficacy and safety of CT-P13 (infliximab) in IBD, including immunogenicity data, show a profile that completely overlaps with the originator”5

“Healthcare professionals have the responsibility to ensure that all information is given to the patient to promote shared decision making, confirming informed consent to treatment and evidence-based patient choice”5

ECCO also encourages the important role of healthcare professionals in patient counselling on biosimilar medicines5

 

 

*CT-P13 was designed with comparable efficacy, safety and quality to reference infliximab, to increase the treatment options for your Crohn’s disease and ulcerative colitis patients.6,7 Increasing real-world experience confirms the CT-P13 clinical efficacy and safety profile.5

CD, Crohn’s disease; ECCO, European Crohn’s and Colitis Organisation; IBD, Inflammatory bowel disease; OLE, Open-label extension; RCT, Randomised clinical trial; UC, Ulcerative colitis.

Šaltiniai: 

1. Gecse KB, et al. J Crohns Colitis 2016;10(2):133-40. 2. Jørgensen KK, et al. Lancet 2017;389:2304-16. 3. QuintilesIMS. MIDAS, February 2017. 4. INFLECTRA® Summary of Product Characteristics. 5. Danese S, et al. J Crohns Colitis 2017;11(1):26-34. 6. European Public Assessment Report: INFLECTRA™. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_asses.... Accessed December 2017. 7. European Medicines Agency. Guidelines on similar biological medicinal products containing monoclonal antibodies - non-clinical and clinical issues. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/ 2012/06/WC500128686.pdf. Accessed December 2017.