Celltrion’s Remsima SC for IBD gains approval in Canada
19 Feb 2024
Drug Approval
Preview
Source: Pharmaceutical Technology
In LIBERTY trials, Remsima SC was shown to be superior to placebo in achieving clinical remission and endoscopic response. Credit: Emily frost / Shutterstock.com.
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).
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.
See Also:Pfizer’s VELSIPITY receives EC approval for ulcerative colitis
Preview
Source: Pharmaceutical Technology
INV-347 by Inversago Pharma for Obesity: Likelihood of Approval
Preview
Source: Pharmaceutical Technology
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.
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.”
For more details,please visit the original website
The content of the article does not represent any opinions of Synapse and its affiliated companies. If there is any copyright infringement or error, please contact us, and we will deal with it within 24 hours.
Organizations
Indications
Targets
Hot reports
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Leverages most recent intelligence information, enabling fullest potential.