Celltrion Healthcare launches Remsima™ SC, the world's first subcutaneous formulation of infliximab in Canada, for the treatment of people with rheumatoid arthritis
- Remsima™ SC offers an innovative treatment option for patients living with chronic inflammatory conditions in Canada
- Remsima™ SC is supported by the CELLTRION CONNECT™ Patient Support Program
- Celltrion Healthcare Canada Limited aims to expand access to innovative and high-quality biologics
TORONTO, June 7, 2021 /CNW/ - Celltrion Healthcare Canada Limited announced today the launch of Remsima™ SC (CT-P13 SC), the world's first subcutaneous formulation of infliximab in Canada for the treatment of adult patients with rheumatoid arthritis (RA). Health Canada granted a notice of compliance (NOC) for Remsima™ SC in Canada for the treatment of adult patients with rheumatoid arthritis (RA) on January 28.1
"We are delighted to be able to launch Remsima™ SC today and to bring the first and only subcutaneous form of infliximab to patients, payers and clinicians in Canada," said Jovan Antunovic, Commercial Director at Celltrion Healthcare Canada. "Our team is strong, growing and proud that Remsima™ SC will be the first product to be commercially available in the Canadian market under our new direct sales marketing strategy and is supported by the comprehensive CELLTRION CONNECT™ patient support program. We will continue to enhance our presence in Canada by collaborating with the different stakeholders to support the company's growth strategy."
Remsima™ SC is commercially available in Canada in 120 mg fixed dose as a pre-filled pen (auto-injector) and is administered as a bi-weekly subcutaneous injection. It is approved in Canada for use in combination with methotrexate for the reduction in signs and symptoms, inhibition of the progression of structural damage and improvement in physical function in adult patients with moderately to severely active rheumatoid arthritis and should be used as maintenance therapy after the completion of an induction period with intravenous infliximab.2
"Rheumatoid arthritis (RA) is a chronic inflammatory autoimmune disease that can lead to irreparable joint destruction if not properly treated," said Professor Edward Keystone, Professor of Medicine, University of Toronto, Toronto, Canada. "Having a subcutaneous formulation of infliximab means patients can have a more flexible dosing schedule and control on how they receive their treatment."
The approval was based on clinical evidence including results from a study that showed switching people with RA from the intravenous (IV) formulation to the SC formulation of CT-P13 treatment at Week 30 was comparable to maintaining CT-P13 SC up to Week 54 (up to Week 64 for safety profile).2,3
Notes to Editors:
About CELLTRION CONNECT™ Patient Support Program
CELLTRION CONNECT™ patient support program is designed to support patients, caregivers, and healthcare providers with access to Remsima™ SC. Interested individuals can find out more about CELLTRION CONNECT™ by visiting www.celltrionconnect.ca/
About CT-P13 (biosimilar infliximab)4, 5, 6
CT-P13 is developed and manufactured by Celltrion, Inc. and was the world's first monoclonal antibody biosimilar approved by the European Commission (EC). It is indicated for the treatment of eight autoimmune diseases including RA and IBD. It was approved by the EC 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 CT-P13 in April 2016 under the trade name Inflectra®. CT-P13 is approved in more than 94 countries (as of June 2021) including the US, Canada, Japan and throughout Europe.
CT-P13 IV is usually given as 3 mg per kg/body weight in RA and as 5 mg per kg/body weight for the other indications. Infliximab IV is given as an infusion over two hours. All patients are monitored for any reactions during the infusion and for at least one to two hours afterwards. The subcutaneous (SC) formulation has the potential to enhance treatment options for the use of infliximab biosimilar by providing high consistency in drug exposure and a convenient method of administration.
CT-P13 SC has received EU marketing authorization for the treatment of people with RA and IBD in November 2019 and July 2020, respectively. In the United States, Remsima® SC will be reviewed through the new drug pathway by the U.S. Food and Drug Administration (FDA) with the outcome expected by 2022.
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 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.com/en-us
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|1.||Government of Canada. Available at: https://health-products.canada.ca/noc-ac/index-eng.jsp|
|2.||Remsima™ SC Product Monograph. Celltrion Healthcare Canada Limited, January 28, 2021.|
|3.||Westhovens R et al. Efficacy, pharmacokinetics and safety of subcutaneous versus intravenous CT-P13 in rheumatoid arthritis: a |
randomized phase I/III trial. Rheumatology (Oxford) 2020 Nov 23;keaa580: doi: 10.1093/rheumatology/keaa580.
|4.||European Medicines Agency Summary of Product Characteristics (SmPC). CT-P13. Available at |
accessed June 2021.
|5.||Yoo DH, Jaworski J, Matyska-Piekarska E et al. A novel formulation of CT-P13 (infliximab biosimilar) for subcutaneous |
administration: One-year results from part one of a Phase I/III randomised controlled trial in patients with rheumatoid arthritis. Poster
(FRI0128). Presented at EULAR 2019.
|6.||Westhovens R, Wiland P, Zawadzki M et al. A novel formulation of CT-P13 (infliximab biosimilar) for subcutaneous administration:|
30-week results from part two of a Phase I/III randomised controlled trial in patients with rheumatoid arthritis. Poster (SAT0170).
Presented at EULAR 2019.
SOURCE Celltrion Healthcare