Are Inflectra and Remsima the Same?
Yes, Inflectra and Remsima are the same biosimilar infliximab product (CT-P13), marketed under different brand names in different regions. 1
Key Facts About CT-P13
CT-P13 is a single biosimilar product approved and marketed as both Remsima and Inflectra, depending on geographic location and distribution agreements 1, 2
Both names refer to the identical formulation with the same physiochemical characteristics, manufacturing process, and clinical profile 3
The European Medicines Agency (EMA) approved CT-P13 as a biosimilar to reference infliximab (Remicade) based on comprehensive comparability data demonstrating pharmacokinetic and pharmacodynamic equivalence 1
Clinical Evidence Supporting Equivalence
The approval of CT-P13 (marketed as both Inflectra and Remsima) was based on rigorous clinical trials:
PLANETRA study in rheumatoid arthritis patients (n=606) demonstrated equivalent efficacy at 54 weeks, with ACR20 response rates of 74.7% for CT-P13 versus 71.3% for reference infliximab 4
PLANETAS study in ankylosing spondylitis patients (n=250) showed comparable pharmacokinetic parameters with 90% confidence intervals within the required 90-125% range for both AUC (104%, 94-115%) and Cmax (101%, 95-109%) 1, 5
Immunogenicity profiles were similar between CT-P13 and reference infliximab, with 41.1% versus 36.0% developing anti-drug antibodies at week 54 in rheumatoid arthritis patients 4
Real-World Use in IBD
In the PANTS observational cohort of 751 Crohn's disease patients treated with infliximab, immunogenicity rates at week 54 were 26% for Remicade and 28% for biosimilar infliximab (Inflectra/Remsima), demonstrating no clinically meaningful difference 1
Important Clinical Considerations
The two brand names do not represent different products - they are simply different commercial names for the same CT-P13 biosimilar 1, 2, 3
Switching between Inflectra and Remsima is not actually "switching" since they are the identical product, unlike switching between different biosimilars or from originator to biosimilar 1
Both names are approved for all indications where reference infliximab is licensed, including rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, psoriasis, Crohn's disease, and ulcerative colitis 2, 3