Celltrion’s Infliximab, the First Monoclonal Antibody Biosimilar, Is Now Remdantry™ in Canada

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• CT-P13, intravenous infliximab, developed and manufactured by Celltrion, is the first monoclonal antibody biosimilar therapy and has been the most established biosimilar treatment in the Canadian market for over 10 years
• Decision reflects Celltrion’s ongoing commitment to ensuring seamless access to high-quality treatment options for patients and healthcare providers in Canada

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TORONTO — Celltrion, Inc., a leading global biopharmaceutical company, announced today that its infliximab biosimilar will be marketed in Canada under the new brand name Remdantry^TM starting April 1, 2025, following approval of the product name change by Health Canada.¹

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As Remdantry uses the same Drug Identification Number (DIN) as Inflectra^®, the formulation, indications and dosages of Remdantry will remain the same as that of Inflectra, which was originally approved by the Health Canada for the treatment of rheumatoid arthritis (RA), plaque psoriasis (PsO), psoriatic arthritis (PsA), and ankylosing spondylitis (AS) in January 2014 and for Crohn’s disease (CD), fistulising Crohn’s disease and ulcerative colitis (UC) in June 2016.²

“For patients with chronic inflammatory diseases requiring long-term treatment, especially those who are currently well-managed, the idea of switching to a different biosimilar can be a sensitive issue,” said Dr. Brian Bressler, MD, MS, FRCPC Head, Division of Gastroenterology, Providence Health Care, University of British Columbia. “It is reassuring to know that while the product name is changing from Inflectra to Remdantry, the medication itself remains exactly the same. Patients who have been on Inflectra can continue their therapy without any need to switch between different biosimilars, ensuring consistency in their care during this transition.”

Celltrion developed and manufactured the world’s first monoclonal antibody biosimilar, followed by the first and only subcutaneous (SC) formulation infliximab, ‘Remsima^® SC’, which was also approved in Canada for the treatment of RA, for maintenance therapy in adults with moderately to severely active ulcerative colitis (UC) and Crohn’s disease (CD).

“Our priority is ensuring a seamless transition for patients and healthcare providers,” said Jungyong Shin, Managing Director at Celltrion Healthcare Canada. “The introduction of Remdantry reflects Celltrion’s consolidation of both the intravenous (IV) and subcutaneous (SC) formulations under our direct commercialization. By doing so, we aim to provide healthcare professionals with a more streamlined prescribing experience, reducing complexity in treatment decisions, while supporting improved patient access to optimal, personalized care.”

During this transition, Celltrion is committed to ensuring continued patient support through its patient support program (PSP). Both brand names – Inflectra and Remdantry – will be available under the same DIN for a six-month phase-in period and healthcare providers can still prescribe Remdantry as Inflectra. After the transition period, prescriptions will be exclusively issued under the new brand name ‘Remdantry’.

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Celltrion remains dedicated to delivering high-quality biosimilar therapies and supporting healthcare professionals and patients throughout this transition.

Notes to Editors:

About Remdantry™, Celltrion’s infliximab, in Canada

Remdantry™ (infliximab for injection) is a biosimilar to the reference biologic drug Remicade^®, that consists of a chimeric immunoglobin G1 (IgG1) monoclonal antibody that binds with high affinity to the human tumour necrosis factor alpha (TNFα). Remdantry is indicated for the treatment of rheumatoid arthritis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease (CD), fistulising Crohn’s disease and ulcerative colitis (UC).

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.

Subcutaneous infliximab (trademarked as Remsima^® SC 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, Inc.

Celltrion is a leading biopharmaceutical company that specialises in researching, developing, manufacturing, marketing and sales of innovative therapeutics that improve people’s lives worldwide. Celltrion is a pioneer in the biosimilar space, having launched the world’s first monoclonal antibody biosimilar. Our global pharmaceutical portfolio addresses a range of therapeutic areas including immunology, oncology, haematology, ophthalmology and endocrinology. Beyond biosimilar products, we are committed to advancing our pipeline with novel drugs to push the boundaries of scientific innovation and deliver quality medicines. For more information, please visit our website www.celltrion.com/en-us and stay updated with our latest news and events on our social media – LinkedIn, Instagram, X, and Facebook.

About Celltrion Healthcare Canada Limited

Celltrion Healthcare Canada 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. Celltrion Healthcare Canada currently has 6 biosimilars including: Remdantry™, Remsima^® SC, Yuflyma^®, Vegzelma™, SteQeyma^® and Omlyclo™. For more information, please visit: https://www.celltrionhealthcare.ca

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Inflectra® is a registered trademark of Pfizer Inc.
Remdantry^TM is a trademark of Celltrion, Inc. and is used under license in Canada

¹ Remdantry Product Monograph. Celltrion, Inc. March 2025. Product Information from Health Canada.
² Inflectra product monograph. Available at: (accessed on February 20, 2025)

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