Celltrion makes case for Remicade biobetter with subcut switch data

IBD
One analysis looked at what happened when 65 inflammatory bowel disease patients switched drug formulation. (kirisa99/iStock/Getty Images Plus)

Celltrion Healthcare is continuing to make the case for switching from intravenous to subcutaneous formulations of infliximab, with the latest data drop suggesting there may be benefits beyond convenience. 

European regulators approved the subcutaneous formulation of Celltrion’s Remicade biosimilar, sold as Remsima SC, late in 2019. The pandemic drove healthcare providers in Europe, notably in the U.K., to switch patients to the subcutaneous product to relieve pressure on hospitals and spare patients the need to visit sites to receive intravenous infusions. Celltrion has now added to early reports of the real-world experiences of switching with data from two studies.

One of the updates is a post hoc analysis of Celltrion’s pivotal randomized trial of the subcutaneous formulation. The analysis looked at what happened when 65 inflammatory bowel disease patients started using the subcutaneous product after spending the first 30 weeks of the clinical trial receiving intravenous infusions.    

Celltrion saw a significant difference in how low the drug concentration fell between doses after switching patients to a subcutaneous formulation. After switching, the proportion of patients who exceeded the target exposure went from 20% to 88%. The change had no effect on clinical response rates, though.

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“The post-hoc analysis indicates that switching from IV to SC infliximab will deliver comparable clinical outcomes for patients with inflammatory bowel disease, including those with Crohn's disease and ulcerative colitis, further highlighting the potential of SC infliximab as an alternative administration route,” Walter Reinisch, the presenting author of the poster, said in a statement.

Celltrion’s second update focused on the difference between patients on Remsima SC monotherapy and combination therapy. The analysis found no significant difference in clinical response rates, leading the presenting author to say the exploratory results suggest the subcutaneous treatment is a viable monotherapy treatment option.