Positive new data on switching of Celltrion's biosimilar Remsima

New clinical data indicate no differences in efficacy, adverse events and immunogenicity when patients with inflammatory bowel disease (IBD) are switched to the biosimilar infliximab Remsima from originator infliximab (Remicade, the reference medicinal product from Johnson & Johnson [NYSE: JNJ).

The study results, presented at United European Gastroenterology Week (UEG Week) 2015 in a satellite symposium sponsored by South Korea’s Celltrion (Kosdaq: 068270), add to growing real-world evidence that patients already being treated with the reference product can be appropriately switched to Remsima, a more cost-effective treatment option.

In the Czech Republic, a total of 74 IBD patients (Crohn’s disease [CD]: 56, ulcerative colitis [UC]: 18) in remission on long term treatment with the RMP were switched to Remsima. After a median follow up of 24 weeks, results from the study showed good efficacy for Remsima with the same maintenance of remission, minimal adverse events – including immunogenicity – and no difference in allergic reactions compared to the reference product. The same trough levels of infliximab were seen in patients receiving Remsima compared to historical data for Remicade.