Celltrion, Inc., a global biopharmaceutical leader, announced today that its infliximab biosimilar will be marketed in Canada under the new brand name Remdantry™ starting April 1, 2025, following Health Canada's approval of the product name change.
The infliximab biosimilar, previously marketed as Inflectra®, was the first monoclonal antibody biosimilar therapy and has established a decade-long presence in the Canadian market. Importantly, the rebranding will not affect the medication itself, as Remdantry™ will maintain the same Drug Identification Number (DIN), formulation, indications, and dosages as Inflectra®.
Ensuring Continuity of Care
For patients with chronic inflammatory conditions requiring long-term treatment, the prospect of switching medications can raise concerns about treatment disruption and potential adverse effects.
"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," explained Dr. Brian Bressler, Head of the Division of Gastroenterology at 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."
This continuity is particularly important for patients with conditions such as rheumatoid arthritis (RA), plaque psoriasis (PsO), psoriatic arthritis (PsA), ankylosing spondylitis (AS), Crohn's disease (CD), and ulcerative colitis (UC) – all conditions for which the biosimilar is approved in Canada.
Strategic Consolidation of Formulations
The rebranding represents part of Celltrion's broader strategy to consolidate both intravenous (IV) and subcutaneous (SC) formulations under direct commercialization. Celltrion previously developed Remsima® SC, the first and only subcutaneous formulation of infliximab, which has also received approval in Canada.
"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 and subcutaneous 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."
Transition Process and Patient Support
To facilitate a smooth transition, Celltrion has implemented a six-month phase-in period during which both brand names – Inflectra® and Remdantry™ – will be available under the same DIN. Healthcare providers can continue to prescribe the medication as Inflectra® during this period.
The company has committed to maintaining its patient support program (PSP) throughout the transition. After the six-month phase-in period concludes, prescriptions will be exclusively issued under the new brand name Remdantry™.
Clinical Significance of Infliximab Biosimilars
Remdantry™ (infliximab for injection) is a biosimilar to the reference biologic drug Remicade®. It consists of a chimeric immunoglobin G1 (IgG1) monoclonal antibody that binds with high affinity to human tumor necrosis factor alpha (TNFα), a key inflammatory mediator in many autoimmune conditions.
The introduction of biosimilars like Remdantry™ has significantly improved access to biologic therapies by offering cost-effective alternatives to reference biologics while maintaining comparable safety and efficacy profiles. This has been particularly important for chronic inflammatory conditions that often require lifelong treatment.
Expanding Biosimilar Portfolio
Celltrion Healthcare Canada currently markets six biosimilars in the Canadian market, including Remdantry™, Remsima® SC, Yuflyma®, Vegzelma™, SteQeyma®, and Omlyclo™. This growing portfolio reflects the company's commitment to expanding patient access to advanced therapies across multiple therapeutic areas.
As a pioneer in the biosimilar space, Celltrion continues to focus on developing high-quality biosimilars while also advancing its pipeline of novel drugs. The company's approach combines innovation with accessibility, aiming to address unmet medical needs while improving affordability and availability of critical medications.
The rebranding of infliximab from Inflectra® to Remdantry™ represents an important step in Celltrion's ongoing efforts to optimize its product portfolio while ensuring that patients maintain access to established treatments without disruption.
