New ECCO statement supports switching to biosimilars for treatment of IBD patients
South Korea’s Celltrion Healthcare (Kosdaq: 068270) welcomes the publication of the latest position paper from the European Crohn’s and Colitis Organization (ECCO) on the use of biosimilars for inflammatory bowel disease (IBD), which supports switching from reference infliximab, US health care giant Johnson & Johnson’s (NYSE: JNJ) blockbuster anti-inflammatory drug Remicade, to biosimilar infliximab.
The ECCO statement covers several aspects related to biosimilars and the key positions are:
- Switching from the originator to a biosimilar in patients with IBD is acceptable following appropriate discussion between physicians, nurses, pharmacists, and patients, and according to national recommendation.
- When a biosimilar product is registered in the European Union, it is considered to be as efficacious as the reference product when used in accordance with the information provided in the Summary of Product Characteristics.
- Demonstration of safety of biosimilars requires large observational studies with long-term follow-up in IBD patients.
- Data for the usage of biosimilars in IBD can be extrapolated from another sensitive indication.
- As for all biologics, traceability should be based on a robust pharmacovigilance system.
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