Health Canada Approves Remsima SC For The Treatment Of Inflammatory Bowel Disease (IBD)

Toronto, ON (BUSINESS WIRE) - Celltrion Healthcare Canada Limited, today announced that Health Canada has approved Remsima™ SC for maintenance therapy in adults with moderately to severely active ulcerative colitis (UC) and Crohn’s disease (CD). Remsima™ SC is a subcutaneous form of infliximab, and was approved by Health Canada in 2021 for the treatment of adult patients with rheumatoid arthritis (RA).¹

The approval was based on clinical evidence, including results from the LIBERTY UC and LIBERTY CD studies that showed the efficacy and safety of Remsima™ SC as maintenance therapy in patients with moderately to severely active UC and CD. Based on the results of the LIBERTY studies, over a 54-week study period Remsima™ SC demonstrated superiority in the results of the primary endpoints of clinical remission (UC and CD) and endoscopic response (CD) compared to placebo as maintenance therapy after induction therapy of intravenous formulation of infliximab in patients with UC and CD. The overall safety profile of Remsima™ SC was similar to that of placebo during maintenance period in both studies with no new safety signals seen.^2,3

“Canada has one of the highest rates of IBD in the world, and these diseases place a burden on individuals, caregivers, and on our healthcare system. There is still an unmet need for new treatment options or modality for patients living with moderate to severe UC and CD. Remsima™ SC now offers this new option for physicians and patients in this space. We are excited about the potential of Remsima™ SC,” said Pr. Peter Lakatos, MD PhD DsC FEBG AGAF, Professor at the Department of Medicine, McGill University, McGill University Health Centre, Montreal General Hospital, Montreal, QC.

“The availability of an infliximab treatment option from Celltrion healthcare Canada, now in a subcutaneous delivery, is an advancement for the patients and healthcare providers in Canada,” said Jungyong Shin, Managing Director at Celltrion Healthcare Canada. “Patients now have the opportunity to choose how and where they receive infliximab treatment; in an infusion center, at a physician’s office, and now with Remsima™ SC, the option to receive treatment at home - providing more flexibility and freedom of choice. We are pleased that with Remsima™ SC patients now have the option to manage their condition in accordance with their lifestyle and we aim to bridge any gap for the patients’ accessibility.”

Notes to Editors:

About Remsima™ SC
Remsima™ SC is a subcutaneous version of Celltrion’s infliximab biosimilar. Remsima™ SC blocks the action of tumor necrosis factor-alpha (TNF-alpha), a protein that can be overproduced in response to certain diseases and cause the immune system to attack normal, healthy parts of the body.

The intravenous formulation of infliximab biosimilar developed and manufactured by Celltrion was the world's first monoclonal antibody biosimilar. It is indicated for the treatment of nine autoimmune diseases including Crohn’s disease (CD) and ulcerative colitis (UC). It was approved by the European Commission under the trade name REMSIMA® in September 2013 and launched in major EU countries in early 2015. The U.S. Food and Drug Administration approved the biosimilar in April 2016 under the trade name INFLECTRA®.

Subcutaneous infliximab (trademarked as REMSIMA™ in Canada) has received Health Canada approval for the treatment of adult patients with moderately to severely active Rheumatoid Arthritis (RA), UC and CD.

About Celltrion Healthcare
Celltrion Healthcare is committed to delivering innovative and affordable medications to promote patients’ access to advanced therapies. Its products are manufactured at state-of-the-art mammalian cell culture facilities, designed and built to comply with Health Canada regulations, the U.S. FDA cGMP and the EU GMP guidelines. Celltrion Healthcare endeavours to offer high-quality cost-effective solutions through an extensive global network that spans more than 110 different countries. For more information, please visit: https://www.celltrionhealthcare.ca

¹ RemsimaTM SC Product Monograph. Celltrion Inc. February 15, 2024. Product information from Health Canada available at: https://pdf.hres.ca/dpd_pm/00074581.PDF. Accessed on February 16, 2024.
² Hanauer SB et al., Subcutaneous infliximab (CT-P13) as maintenance therapy for Crohn’s disease: A phase 3, randomized, placebo-controlled study (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 maintenance therapy for ulcerative colitis: A phase 3, randomized, placebo-controlled study: Results of the LIBERTY-UC study. Gastroenterology. 2023;164(Supplement_6):S1083-S1084; [Digestive Disease Week 2023, Presentation number Tu1701].

REMSIMA™ is a trademark of Celltrion, Inc. and is used under license.
Inflectra® is a registered trademark of Hospira, a Pfizer Company.

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