Abstract
This commentary summarizes a collection of key references published within the last ten years, and identifies pharmacologic research directions to improve treatment access and success through greater biosimilar or “follow-on” biologic utilization combined with other targeted small molecule agents that possess unique pathophysiologic mechanisms for inflammatory bowel diseases (IBD) in adult and pediatric patients. Since they are not identical to the originator or reference biologic agent, all biosimilars are not generically equivalent. However, in the US and other countries, they are considered therapeutically interchangeable if the manufacturer has demonstrated no clinically meaningful differences from the reference product. Comparisons of different clinical initiation and switching scenarios are discussed with reference to interchangeability, immunogenicity, nocebo effect, cost effectiveness, and time courses for discontinuation rates.
Subject
Gastroenterology,Hepatology
Reference85 articles.
1. Managing Costs and Care with Biosimilarshttps://www.cardinalhealth.com/content/dam/corp/web/documents/data-sheet/cardinal-health-biosimilars-chart.pdf
2. Vedolizumab Biosimilar-Research Grade [ICH4035]-ichorbiohttps://ichor.bio/product/vedolizumab-biosimilar-research-grade-ich4035/
3. SAMSUNG BIOEPIS Initiates Phase 1 Clinical Trial for SB17, Proposed Biosimilar to Stelara (Ustekinumab)https://www.samsungbioepis.com/en/newsroom/newsroomView.do?idx=221¤tPage=1
4. Optimizing the use of biological therapy in patients with inflammatory bowel disease
5. Best practices on immunomodulators and biologic agents for ulcerative colitis and Crohn's disease in Asia