Celltrion Healthcare receives EU marketing authorisation for world’s first subcutaneous formulation of infliximab, Remsima SCTM, for the treatment of people with rheumatoid arthritis

·         Remsima SC™ is the subcutaneous version of Celltrion Healthcare’s infliximab biosimilar, CT-P13

·         European Union (EU) marketing approval is based on the phase I/III study to evaluate pharmacokinetics, efficacy and safety between CT-P13 SC and the intravenous (IV) version of CT-P13 in people with active rheumatoid arthritis (RA)

·         This novel formulation provides an alternative administration option for European physicians and their patients

[26 NOVEMBER] - INCHEON, SOUTH KOREA - Celltrion Healthcare today announced that the European Commission has approved Remsima SC^™ (CT-P13 SC, biosimilar infliximab) for patients with RA.^[1] Remsima SC^™ is the world’s first subcutaneous formulation of infliximab.

Remsima SC™ is approved in the EU for the treatment of people with rheumatoid arthritis in combination with methotrexate (MTX), in adult patients with active RA when the response to disease-modifying anti-rheumatic drugs (DMARDs), including MTX, has been inadequate; and in adult patients with severe, active and progressive disease not previously treated with MTX or other DMARDs.¹

The approval is based on clinical evidence including results from a study that showed switching people with RA from the intravenous (IV) formulation to the subcutaneous (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] The study was presented at this year’s American College of Rheumatology Congress.

“The approval of Remsima SC™ in Europe gives patients the opportunity to administer the treatment themselves as an injection, giving them more control over their own treatment”, said Professor Rene Westhovens, Rheumatologist at the University Hospitals KU Leuven, Belgium. “Remsima SC™ has been shown to have a stable potency, and patients with RA on Remsima SC™ develop fewer anti-drug antibodies - which can improve the effectiveness of a treatment - compared with those on CT-P13 IV”.

With the availability of the novel formulation of infliximab, patients could now be treated with a more personalised and convenient treatment option. Remsima SC™ can be injected by patients themselves, which has the potential to significantly reduce hospital visits, as well as save time normally required for hospital-administered IV treatment.

Celltrion has also submitted a further variation to the marketing authorization of Remsima SC™ to extend the indication to inflammatory bowel disease and the approval decision is expected in mid-2020.

“The development of Remsima SC™ demonstrates that Celltrion Healthcare is not just a biosimilar company, it is also an innovative company that strives for novel solutions such as the SC formulation of biosimilar infliximab. We develop cost-effective and patient-centered treatments to enable more patients to gain access to biologics that have proven efficacy and safety profiles,” said Hyoung-Ki Kim, Vice Chairman at Celltrion Healthcare. “Celltrion Healthcare has expanded its business operations to strengthen the company’s presence in the major European markets. Celltrion expects to launch Remsima SC™ across Europe in the first quarter of 2020”.

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

About CT-P13 (biosimilar infliximab)^{1,[3],[4],[5]}
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 89 countries (as of November 2019) including the US, Canada, Japan and throughout Europe.

CT-P13 IV is usually given as 3mg per kg/body weight in RA and as 5mg 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 a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) and EU marketing authorisation for the treatment of people with RA. A phase III study of CT-P13 SC for people with inflammatory bowel disease (IBD) is underway. Celltrion has submitted a further variation to the marketing authorization of CT-P13 SC to extend the indication to inflammatory bowel disease.

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 US 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 120 different countries. For more information please visit: https://www.celltrionhealthcare.com/en-us

[3] 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.

[4] 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.

[5] 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 November 2019].

[1] European Medicines Agency Summary of Product Characteristics (SmPC). Remsima SC^™.

[2] Westhovens R, Wiland P, Zawadzki M et al. Efficacy and Safety of a Novel Subcutaneous Formulation of CT-P13 over the 1-year Treatment Period and After Switching from Intravenous CT-P13 in Patients with Active Rheumatoid Arthritis: Results from Part 2 of Phase I/III Randomized Controlled Trial [abstract]. Arthritis Rheumatol. 2019; 71 (suppl 10). Available at: https://acrabstracts.org/abstract/efficacy-and-safety-of-a-novel-subcutaneous-formulation-of-ct-p13-over-the-1-year-treatment-period-and-after-switching-from-intravenous-ct-p13-in-patients-with-active-rheumatoid-arthritis-results-fro/. [Last accessed November 2019].