- Remdantry™ (previously known as Inflectra®), developed and manufactured by Celltrion, is the first monoclonal antibody biosimilar infliximab in Canada and will be commercially available across Canada as of April 1, 2025
- Celltrion offers a full-service patient support program offering a wide range of services from financial assistance to patient education in Canada
TORONTO–(BUSINESS WIRE)–Celltrion, Inc., a leading global biopharmaceutical company, announced that Remdantry™ will be available in Canada as of April 1, 2025. Remdantry™, previously known as Inflectra®, is the new brand name for its first monoclonal antibody biosimilar to Remicade (infliximab) in Canada.
Celltrion received Health Canada Notice of Compliance (NOC) for Remdantry on March 7, 2025.
Remdantry™ will use the same Drug Identification Number (DIN) as Inflectra®, and 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 2016.1
“The availability of Remdantry™ in Canada is a step forward in Celltrion’s long-standing commitment to providing ongoing support to Canadian patients who have been using our products for years,” said Jungyong Shin, Managing Director at Celltrion Healthcare Canada. “Celltrion has a long-standing track record of manufacturing Inflectra® for over 10 years and will continue to provide Remdantry™ to the Canadian market as planned. Given that the product will be sourced from South Korea, Celltrion does not anticipate any disruptions to the supply chain from external market factors, including tariffs considerations, ensuring a steady and uninterrupted availability for Canadian patients.”
Celltrion offers CELLTRION CONNECT™, a patient support program tailored to support patients and healthcare providers. The program provides guidance with reimbursement navigation, financial assistance, infusion and nurse support services for patients throughout their treatment.
In Canada, Celltrion has received Health Canada approval for six biosimilars including: Remdantry™, Remsima® SC, Yuflyma®, Vegzelma™, SteQeyma® and Omlyclo™.
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 immunoglobulin 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 (RA), plaque psoriasis (PsO), psoriatic arthritis (PsA), ankylosing spondylitis (AS), Crohn’s disease (CD), fistulising Crohn’s disease and ulcerative colitis (UC).
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
Inflectra® is a registered trademark of Pfizer Inc.
RemdantryTM is a trademark of Celltrion, Inc. and is used under license in Canada
1 Inflectra product monograph. Available at: https://webfiles.pfizer.com/file/b15806e9-b05d-468c-9bb3-ee2595f34e0d?referrer=ccb731e5-4f2d-4f4a-b2dc-e5e912145fc6 (accessed on March 6, 2025)
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