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Biosimilars in IBD: from theory to practice
Silvio Danese1,2, Stefanos Bonovas2, Laurent Peyrin-Biroulet3
1Department of Biomedical Sciences, Humanitas University, Via Manzoni 113, 20089 Rozzano, Milan, Italy.
Nature Reviews. Gastroenterology & Hepatology
|October 13, 2016
Summary
Biosimilars offer increased access to biologic therapies for inflammatory bowel disease (IBD). This review clarifies the scientific basis of biosimilars and their current use in IBD management.
Area of Science:
- Immunology
- Gastroenterology
- Pharmacology
Background:
- Biologic agents have transformed treatment for severe diseases.
- Expiring patents allow for biosimilar development, potentially lowering costs and increasing access.
- Biosimilars are highly similar, but not identical, to originator biologics.
Purpose of the Study:
- To review the scientific principles of biosimilars.
- To discuss the current evidence for biosimilar use in Inflammatory Bowel Disease (IBD).
- To address physician concerns regarding biosimilar efficacy and safety.
Main Methods:
- Review of regulatory guidelines from Europe and the USA.
- Analysis of published clinical trial data and real-world evidence for biosimilars in IBD.
- Discussion of scientific literature on biosimilar extrapolation and interchangeability.
Main Results:
- CT-P13 and SB2 are approved biosimilars to infliximab, with others in development.
- Physician understanding and acceptance of biosimilars are influenced by their similar-but-not-identical nature.
- Extrapolation of efficacy and safety data across indications is a key aspect of biosimilar approval.
Conclusions:
- Biosimilars represent a significant advancement in IBD treatment accessibility.
- Ongoing research and physician education are crucial for widespread biosimilar adoption.
- The scientific framework supports the safe and effective use of biosimilars in IBD.
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