Infliximab biosimilar GP1111: a review of 5 years' post-approval experience

Area of Science:

• Immunology
• Pharmacology
• Rheumatology

Background:

• Infliximab is a crucial biologic therapy for autoimmune diseases.
• GP1111 is a recently approved biosimilar to infliximab in Europe.
• Review focuses on rheumatoid arthritis (RA) and inflammatory bowel disease (IBD) indications.

Purpose of the Study:

• To review the approval process and evidence for GP1111.
• To assess preclinical, clinical, and real-world data for GP1111.
• To evaluate the safety and efficacy of GP1111 in RA and IBD.

Main Methods:

• Review of preclinical, clinical (Phase III REFLECTIONS trial), and real-world data.
• Analysis of switching studies from reference infliximab and other biosimilars.
• Inclusion of budget impact analysis for RA treatment.

Main Results:

• Phase III trial confirmed GP1111's similar efficacy and safety to reference infliximab in RA.
• Switching to GP1111 showed no adverse impact on efficacy or safety.
• Real-world data and budget impact analysis support GP1111's cost-effectiveness and continued use.

Conclusions:

• Five years of post-approval experience support GP1111's safety and efficacy.
• Clinical and real-world evidence validate GP1111's use in all approved indications.
• GP1111 is a safe, effective, and cost-effective treatment option for RA and IBD.