StemCell Therapy

TORONTO, Feb. 1, 2021 /CNW Telbec/ - Celltrion Healthcare Canada Limited announced today that Health Canada has granted a notice of compliance (NOC) for Remsima SC (CT-P13 SC) in Canada for the treatment of adult patients with rheumatoid arthritis (RA).

Rheumatoid arthritis is the most common chronic inflammatory joint disease and approximately 374,000 Canadians over the age of 16 live with rheumatoid arthritis.1

Remsima SC 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. Remsima SC should be usedas maintenance therapy after the completion of an induction period with intravenous infliximab.2The Health Canada NOC issued for Remsima SC is based on clinical evidence that showed the clinical response to Remsima subcutaneous (SC) formulation was comparable to CT-P13 IV up to 1 year. It was also shown that switching people with RA from the IV formulation to RemsimaTM SC at Week 30 was comparable to maintaining RemsimaTM SC up to Week 54 (up to Week 64 for safety profile).2,3

"Remsima SC has been shown to have a similar efficacy and safety profile to CT-P13 IV. Remsima SC may also enhance treatment options for the use of infliximab by providing high consistency in drug level and exposure," said Professor Edward Keystone, Professor of Medicine, University of Toronto, Toronto, Canada. "The approval of Remsima SC in Canada provides patients the opportunity to administer the treatment at home, giving physicians and patients more control over their treatment."

With the availability of the subcutaneous formulation of infliximab, patients could now be treated with a more personalized and convenient treatment option. Remsima SC can be injected by patients themselves, which has the potential to save time since it will not require in-clinic administered IV treatment.

As part of Celltrion's strategy to expand its global presence and build a direct sales network, Celltrion Healthcare has established an entity in Canada to manage sales and marketing activities for Remsima SC.

"We are delighted to bring the first subcutaneous form of infliximab to patients, payers and clinicians in Canada. We are proud that RemsimaSC will be the first product to enter the Canadian market under our new direct sales marketing strategy. We plan to strengthen our presence in Canada and support the company's growth,"said Jovan Antunovic, Senior Vice President and Commercial Director at Celltrion Healthcare Canada.

Celltrion has applied for patent protection, until 2038, for Remsima SC in approximately 100 countries throughout North America, Europe and Asia.

Notes to Editors:

About CT-P13 (biosimilar infliximab)4-6

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 January 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. Celltrion has also developed a subcutaneous (SC) formulation of infliximab that has three administration options: via a pre-filled pen (auto-injector), pre-filled syringe or pre-filled syringe with needle safeguard. The 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

References

1.

Government of Canada. Available at:https://www.canada.ca/en/public-health/services/publications/diseases-conditions/rheumatoid-arthritis.html.

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 http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002576/WC500150871.pdf. Last accessed January 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

For further information: Media Relations Contact: [emailprotected], [emailprotected]

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Celltrion Healthcare receives Health Canada marketing authorization for world's first subcutaneous formulation of infliximab, Remsima SC, for the...

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