Well being Canada Approves Remsima™ SC for the Therapy of Inflammatory Bowel Illness (IBD)


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TORONTO — Celltrion Healthcare Canada Restricted, as we speak introduced that Well being Canada has authorised Remsima SC for upkeep remedy in adults with reasonably to severely energetic ulcerative colitis (UC) and Crohn’s illness (CD). Remsima SC is a subcutaneous type of infliximab, and was authorised by Well being Canada in 2021 for the therapy of grownup sufferers with rheumatoid arthritis (RA).1

The approval was primarily based on scientific proof, together with outcomes from the LIBERTY UC and LIBERTY CD research that confirmed the efficacy and security of Remsima SC as upkeep remedy in sufferers with reasonably to severely energetic UC and CD. Primarily based on the outcomes of the LIBERTY research, over a 54-week research interval Remsima SC demonstrated superiority within the outcomes of the first endpoints of scientific remission (UC and CD) and endoscopic response (CD) in comparison with placebo as upkeep remedy after induction remedy of intravenous formulation of infliximab in sufferers with UC and CD. The general security profile of Remsima SC was just like that of placebo throughout upkeep interval in each research with no new security indicators seen.2,3

“Canada has one of many highest charges of IBD on this planet, and these illnesses place a burden on people, caregivers, and on our healthcare system. There may be nonetheless an unmet want for brand spanking new therapy choices or modality for sufferers dwelling with average to extreme UC and CD. Remsima SC now presents this new possibility for physicians and sufferers on this area. We’re excited in regards to the potential of Remsima SC,” mentioned Pr. Peter Lakatos, MD PhD DsC FEBG AGAF, Professor on the Division of Medication, McGill College, McGill College Well being Centre, Montreal Common Hospital, Montreal, QC.

“The supply of an infliximab therapy possibility from Celltrion healthcare Canada, now in a subcutaneous supply, is an development for the sufferers and healthcare suppliers in Canada,” mentioned Jungyong Shin, Managing Director at Celltrion Healthcare Canada. “Sufferers now have the chance to decide on how and the place they obtain infliximab therapy; in an infusion middle, at a doctor’s workplace, and now with Remsima SC, the choice to obtain therapy at residence – offering extra flexibility and freedom of alternative. We’re happy that with Remsima SC sufferers now have the choice to handle their situation in accordance with their life-style and we purpose to bridge any hole for the sufferers’ accessibility.”

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Notes to Editors:

About Remsima SC

Remsima SC is a subcutaneous model of Celltrion’s infliximab biosimilar. Remsima SC blocks the motion of tumor necrosis factor-alpha (TNF-alpha), a protein that may be overproduced in response to sure illnesses and trigger the immune system to assault regular, wholesome elements of the physique.

The intravenous formulation of infliximab biosimilar developed and manufactured by Celltrion was the world’s first monoclonal antibody biosimilar. It’s indicated for the therapy of 9 autoimmune illnesses together with Crohn’s illness (CD) and ulcerative colitis (UC). It was authorised by the European Fee below the commerce identify REMSIMA® in September 2013 and launched in main EU nations in early 2015. The U.S. Meals and Drug Administration authorised the biosimilar in April 2016 below the commerce identify INFLECTRA®.

Subcutaneous infliximab (trademarked as REMSIMA® in EU) has obtained Well being Canada approval for the therapy of grownup sufferers with reasonably to severely energetic Rheumatoid Arthritis (RA), UC and CD.

About Celltrion Healthcare

Celltrion Healthcare is dedicated to delivering modern and reasonably priced medicines to advertise sufferers’ entry to superior therapies. Its merchandise are manufactured at state-of-the-art mammalian cell tradition services, designed and constructed to adjust to Well being Canada laws, the U.S. FDA cGMP and the EU GMP tips. Celltrion Healthcare endeavours to supply high-quality cost-effective options by means of an intensive international community that spans greater than 110 completely different nations. For extra info, please go to: https://www.celltrionhealthcare.ca

1 Remsima SC Product Monograph. Celltrion Inc. February 16, 2024. Product info from Well being Canada obtainable at: https://pdf.hres.ca/dpd_pm/00069836.PDF. Accessed on February 16, 2024.
2 Hanauer SB et al., Subcutaneous infliximab (CT-P13) as upkeep remedy for Crohn’s illness: A section 3, randomized, placebo-controlled research (LIBERTY-CD). Gastroenterology. 2023;164(Supplement_6):S220-S221; [Digestive Disease Week 2023, Presentation number 1028].
3 Sands BE et al., Subcutaneous infliximab (CT-P13 SC) as upkeep remedy for ulcerative colitis: A section 3, randomized, placebo-controlled research: Outcomes of the LIBERTY-UC research. Gastroenterology. 2023;164(Supplement_6):S1083-S1084; [Digestive Disease Week 2023, Presentation number Tu1701].

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