Celltrion Healthcare Canada has announced that its Remsima SC, a subcutaneous version of its infliximab biosimilar, has obtained approval for use as maintenance therapy for inflammatory bowel disease (IBD).
The treatment is now approved by Health Canada for patients with moderately to severely active ulcerative colitis (UC) and Crohn’s disease (CD).
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The approval was based on positive clinical data from the LIBERTY UC and LIBERTY CD clinical trials.
Both studies demonstrated the safety and efficacy of Remsima SC as a maintenance treatment in people with UC and CD over 54 weeks.
Remsima SC showed superiority in achieving the primary endpoints of clinical remission and endoscopic response versus placebo.
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This was observed in patients receiving maintenance therapy after induction with the intravenous formulation of infliximab.
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By GlobalDataThe safety profile of Remsima SC during the maintenance period was comparable to that of the placebo in both studies.
No new safety concerns were reported, highlighting the treatment’s safety for long-term use.
Remsima SC works by blocking the action of tumour necrosis factor-alpha, often overproduced in autoimmune ailments, which leads to the immune system attacking healthy body parts.
The intravenous formulation of infliximab biosimilar was the first monoclonal antibody biosimilar to be approved globally.
It is currently indicated for nine autoimmune diseases, including UC and CD.
The biosimilar was first approved by the European Commission as REMSIMA in September 2013 and subsequently launched in major European countries in early 2015.
With the latest Health Canada approval, Remsima SC is now an option for patients in the country with rheumatoid arthritis, UC and CD, offering a subcutaneous route of administration for convenience and ease in treatment management.
Celltrion Healthcare Canada managing director Jungyong Shin stated: “The availability of an infliximab treatment option […] in a subcutaneous delivery is an advancement for the patients and healthcare providers in Canada.
“Patients now have the opportunity to choose how and where they receive infliximab treatment: in an infusion centre, at a physician’s office and now with Remsima SC, the option to receive treatment at home – providing more flexibility and freedom of choice.”
