Update on biosimilars in inflammatory bowel disease: Position and recommendations in Mexico

Area of Science:

• Gastroenterology
• Immunology
• Pharmacology

Background:

• Biosimilars are non-originator biologic drugs demonstrating comparable quality, efficacy, and safety to reference biologics.
• Clinical trials show infliximab and adalimumab biosimilars are comparable to originators in various autoimmune diseases.
• Controversy exists regarding biosimilar use in inflammatory bowel disease (IBD) due to limited evidence in specific patient populations and switching scenarios.

Purpose of the Study:

• To critically analyze the use of biosimilars in inflammatory bowel disease.
• To evaluate evidence on biosimilar interchangeability, indication extrapolation, efficacy, safety, and immunogenicity.
• To assess the clinical impact of Mexican health regulations on biosimilar adoption in IBD.

Main Methods:

• Critical review of existing scientific literature and clinical trial data.
• Analysis of evidence regarding biosimilar efficacy and safety in IBD patients.
• Examination of regulatory frameworks, specifically Mexican health regulations.

Main Results:

• Evidence suggests biosimilars for infliximab and adalimumab are comparable to originators in autoimmune diseases.
• Limited evidence exists for biosimilar efficacy and safety in IBD, particularly for treatment-naïve patients and those switched from originator biologics.
• Mexican regulations and their clinical impact on biosimilar use in IBD require further evaluation.

Conclusions:

• Biosimilars present potential cost-benefits for patients and healthcare systems in IBD management.
• Further research is needed to establish robust evidence for biosimilar use and interchangeability in IBD.
• Clear positioning and recommendations for biosimilar adoption in IBD are necessary, considering regulatory landscapes.