In LIBERTY trials, Remsima SC was shown to be superior to placebo in achieving clinical remission and endoscopic response. Credit: Emily frost / Shutterstock.com.
This was observed in patients receiving maintenance therapy after induction with the intravenous formulation of infliximab.
The 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.
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.”
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