Business Wire

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

Share

Celltrion Healthcare today announced that the European Commission has approved Remsima SC (CT-P13 SC, biosimilar infliximab) for patients with RA.1 Remsima SCis 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 personalized 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.

-- ENDS --

Notes to Editors:

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

References


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].

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].

Contact information

Zuzanna Grzeskiewicz
zgrzeskiewicz@hanovercomms.com
+44 (0)20 3817 6597

Preetika Ramjoorawon
pramjoorawon@hanovercomms.com
+44 (0)20 3817 6766

About Business Wire

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

HighRes Biosolutions and Novo Nordisk partner to transform drug discovery in automated Lab of the Future24.1.2020 17:00:00 EETPress release

HighRes Biosolutions and Novo Nordisk A/S today announced that they will collaborate to design a state-of-the-art robotic platform for high-throughput biologics engineering and characterisation. The integration of a multi-system robotics platform with sophisticated software control architecture will enable a digital transformation and accelerated discovery for Novo Nordisk’s peptide and large molecule therapeutics research. “In order to maintain our leadership within biologics engineering we are investing in a fully automated and digital design platform. This investment is linked to our build-up in AI and advanced analytics and demonstrates Novo Nordisk’s commitment as a world leading biologics research company,” said Lars Fogh Iversen, senior vice president, Global Research Technologies, Novo Nordisk. The platform will comprise several highly automated and integrated cells for production, characterisation and functional analysis of thousands of biologic compounds every month. Its scop

Conquest Invests in 5 Greenfield Onshore Wind Parks Totalizing 43MW in the Flanders Region24.1.2020 15:37:00 EETPress release

Conquest, acting through the Conquest Sustainable Infrastructure fund, announced the transaction was closed after an exclusive agreement had been reached with ENGIE Electrabel. Conquest acquires 51% of a portfolio expected to provide 111 GWh per annum of renewable power representing the annual electricity consumption of about 32,000 Belgian homes from early 2021 onwards. The projects benefit from 15 to 20-year green certificates local remuneration schemes, and thus generate yearly secured revenues. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200124005221/en/ Credit: Electrabel While the energy and digital transitions continue to drive the infrastructure sector, Conquest keeps building its diversified sustainable real asset portfolio in Western European markets. The success lies in years of collaboration and long-lasting partnerships with fellow industry experts who can notably facilitate access to new growth opportunities

Fluence Expands EMEA Footprint with Horticulture Partners in Papenburg, Germany24.1.2020 14:00:00 EETPress release

Fluence by OSRAM (Fluence), a leading global provider of energy-efficient LED lighting solutions for commercial cannabis and agriculture production, announced today it is expanding its presence in the Emsland region of Germany through partnerships with growers and other horticulture specialists operating out of Papenburg. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200124005109/en/ Friedrich Schulz’s 5.5 hectare farm—which grows herbs year-round in addition to lettuce, peppers and chives—utilizing VYPR 2p fixtures. (Photo: Business Wire) Given Papenburg’s decades-long history of attracting horticulture experts, Fluence’s innovative lighting solutions for horticulture are a natural fit for the region’s tomato, cucumber, leafy greens and herb growers. Forging connections with Papenburg’s horticultural leaders Elektro Evers, an engineering firm specializing in greenhouse technology, is Fluence’s exclusive systems integrator

HCL Technologies Honors Global Goodwill Champions at the 2020 World Economic Forum in Davos24.1.2020 12:47:00 EETPress release

HCL Technologies (HCL), a leading global technology company, today presented its Wave Maker Awards 2020, commemorating global goodwill champions from around the world. The award ceremony, which was held at the HCL Pavilion in Davos, celebrated organizations and individuals passionately committed to such noble causes as diversity & inclusion, education & community upliftment, environment & sustainability, and technology for change. Special guest at the awards was Australian cricket legend Glenn McGrath, who is also founder of the McGrath Foundation, which provides support for Australian women diagnosed with breast cancer and their families. The award recipients were; Lois Auta, Founder and Executive Director of Cedar Seed Foundation, which supports persons with disabilities to participate in all aspects of life; Chido Govera, Founder and Director of The Future of Hope Foundation (TFoHF), which supports marginal and vulnerable members of society through entrepreneurial and self-developme

Ipsen’s palovarotene clinical program in fibrodysplasia ossificans progressiva reaches prespecified interim analysis futility criteria24.1.2020 09:00:00 EETPress release

Regulatory News: Ipsen (Euronext: IPN; ADR: IPSEY) today announced the decision to pause dosing patients in the global Phase III (PVO-1A-301) study designed to evaluate the efficacy and safety of palovarotene in patients with fibrodysplasia ossificans progressiva (FOP), as well as the ongoing Phase II (PVO-1A-202/204) extension studies. In both the Phase III and Phase II extension studies, palovarotene is dosed both chronically (daily) and episodically (during flare-ups). The decision to pause dosing patients in the trial is based on results of a futility analysis reviewed by the Independent Data Monitoring Committee (IDMC) as part of the prespecified interim analysis. The results of a futility analysis indicated that the Phase III FOP trial was unlikely to meet its primary efficacy endpoint (annualized change in new HO volume as compared with Natural History Studyi) upon completion. Despite the results of the prespecified interim analysis, signals of encouraging therapeutic activity w

Amazentis Announces the Launch of Timeline™ Cellular Nutrition at the World Economic Forum in Davos23.1.2020 23:56:00 EETPress release

Amazentis announces the debut of Timeline, a next generation nutrition product designed to promote healthy aging, as part of the Swiss Food & Nutrition Valley in the House of Switzerland at the World Economic Forum in Davos, Switzerland. Given the increase in the aging population globally -- according to a 2019 Deutsche Bank study, there are more people on Earth older than sixty five than younger than five for the first time -- it is imperative for consumers to take proactive measures to maintain a high quality of life, for as long as they live. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200123005820/en/ (Photo: Business Wire) Timeline contains the proprietary nutrient Mitopure™, a highly pure form of Urolithin A. After a decade of rigorous research by leading scientists around the world, Mitopure has been shown to help counter age-associated cellular and muscular decline by revitalizing the mitochondria, the powerplants

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom