Celltrion Healthcare receives positive CHMP opinion for subcutaneous formulation of infliximab, Remsima ® SC, for direct use of subcutaneous therapy without IV loading in adults with rheumatoid arthritis
Celltrion Healthcare today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended Remsima® SC for direct use of subcutaneous therapy without IV loading in patients with rheumatoid arthritis (RA).1
As a result of the CHMP opinion, if agreed by European Commission (EC), Remsima® SC 120 mg can be used without IV infusion both for new and existing RA patients. The recommended posology for newly diagnosed or newly infliximab-initiated patients, suggests that Remsima® SC should be initiated as a subcutaneous injection at week 0 and additional injections will be given at week 1, 2, 3 and 4 after the first injection. Then, maintenance therapy will be followed every 2 weeks thereafter. For existing patients, Remsima® SC is administered without additional IV loading 8 weeks after last administration of the infliximab IV.
“IV administration of infliximab requires frequent hospital visits which can pose a challenge to some patients especially given the current COVID-19 pandemic,” said Professor Roberto Caporali, Professor of Rheumatology at the University of Milan and Head of Rheumatology Unit of Gaetano Pini Hospital, Milan Italy. “The direct subcutaneous induction of the SC formulation of infliximab could potentially shorten drug administration time via self-administration at home, reduce healthcare practitioner time and burden on healthcare system, as well as offering additional flexibility and convenience for patients.”
Previous pharmacoeconomic model which estimates delivering subcutaneous infliximab with IV induction regimen yields savings of 21 million GBP compared to IV infliximab when treating British RA patients in one-year time frame. Remsima® SC without IV induction can generate additional saving of 14 million GBP. All models project potential savings from IV administration costs thus societal gain may be greater than the estimates.2
“Today’s positive CHMP opinion marks a step forward in our goal to provide flexible treatment schedules to patients with rheumatoid arthritis especially under COVID-19 situation,” said Dr. HoUng Kim, Ph.D., Head of Medical and Marketing Division at Celltrion Healthcare. "If the recommendation of EMA is agreed by EC, Remsima® SC could be used without IV infusion for newly initiated patients as well as patients currently on infliximab treatment.”
- ENDS -
Notes to Editors:
About Remsima® (CT-P13) intravenous (IV) formulation1
Remsima® IV is usually given as 3 mg per kg/body weight in rheumatoid arthritis (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.
About Remsima® CT-P13 subcutaneous (SC) formulation3,4
A 120 mg fixed dose of Remsima® SC has been granted marketing authorisation in the EU, in adults regardless of body weight, in all previously approved indications for the IV formulation. Remsima® SC 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.
About CT-P13 (biosimilar infliximab)
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 US FDA approved CT-P13 in April 2016 under the trade name Inflectra®. CT-P13 is approved in more than 96 countries (as of March 2021) including the US, Canada, Japan and throughout Europe.
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 110 different countries. For more information please visit: https://www.celltrionhealthcare.com/en-us
1 Opinion of the committee for medicinal products for human use on a type II variation to the terms of the marketing authorisation | European Medicines Agency (europa.eu). [Last accessed 29 March 2021]
2 M. Perry et al. Budget Impact Analysis of Introducing subcutaneous infliximab CT-P13 SC from the UK payer perspective. Abstract presented at EULAR 2020
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.
About Business Wire
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
A Digital Transformation: Mary Kay Inc. Launches Immersive Virtual Experience Platform Suite 13 TM15.4.2021 15:03:00 CEST | Press release
Global beauty brand Mary Kay Inc. and its Mary Kay Global Design Studio present Suite 13TM, an innovative virtual beauty experience that leverages the use of virtual reality to digitize Mary Kay's first virtual pop-up showroom. Designed with the latest virtual reality technology, the new Suite 13TM offers Mary Kay Independent Beauty Consultants and their customers a 360-degree, 3D beauty experience where users can virtually browse the beauty brand’s portfolio of skin care as well as explore the company and its founder Mary Kay Ash’s history. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210415005306/en/ The new Suite 13™ offers Mary Kay Independent Beauty Consultants and their customers a 360-degree, 3D beauty experience. (Photo: Mary Kay Inc.) The new Suite 13TM invites users to tour through virtual “rooms”. Upon entering the “Lobby”, users can learn about the Company’s global legacy. The other virtual rooms include the “P
Conviva Works With ServiceNow to Provide Next Generation Customer Service for Streaming Customers15.4.2021 15:00:00 CEST | Press release
Conviva, the intelligence cloud for streaming media, today announced that its streaming insights data will be integrated with ServiceNow telecom and media industry solutions. This new integration will enable streaming providers to offer more reliable streaming services and personalized customer care experiences to drive user acquisition, reduce operational costs and increase customer lifetime value. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210415005156/en/ Conviva and ServiceNow Provide Next Generation Customer Service For Streaming Customers (Graphic: Business Wire) Conviva’s integration with ServiceNow extends ServiceNow’s offerings within the telecom and media industry and will help streaming customers to automate proactive case creation and ticket generation to identify and diagnose incidents across the entire video delivery supply chain. Adding this additional layer of automation to root cause analysis delivers im
Thales IoT SAFE to Secure Cloud Connectivity for New Internet of Things Services in Canada15.4.2021 15:00:00 CEST | Press release
Thales technology is at the heart of a new Canadian IoT project that is enabling instant, secure and scalable cloud connectivity for SIM/eSIM-enabled IoT. Working alongside TELUS, a leading Canadian wireless network operator, and the Canadian Internet Registration Authority (CIRA), the project’s certification partner, Thales is supplying SIMs and the IoT server, both compliant with the GSMA IoT SAFE specifications. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210415005017/en/ (Photo: Thales) The Thales IoT SAFE service offers an interoperable framework enabling swift deployment of IoT applications. Delivered in a plug & play SaaS mode, it benefits minimal integration effort. It creates a scalable and automatic environment for cloud data security of SIM-equipped devices with a remote management feature. TELUS continues its IoT expansion with devices across Canada, offering enterprises an innovative system that eliminates th
First Patient Enrolled in PROTECT IV Randomized Controlled Trial of Impella15.4.2021 14:03:00 CEST | Press release
Abiomed (NASDAQ:ABMD) announced today that the first patient has been enrolled in PROTECT IV, a large, prospective, multi-center randomized controlled trial (RCT) that is designed to provide the level of clinical evidence needed to achieve a Class I guideline recommendation for Impella in high-risk percutaneous coronary intervention (HRPCI). The first patient was enrolled at Ascension St. John Hospital in Detroit by Dr. Ted Schreiber, chief of cardiology at Ascension St. John Macomb-Oakland Hospital and Dr. Amir Kaki, interventional cardiologist and director of mechanical circulatory support at Ascension St. John Hospital. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210415005234/en/ Impella Clinical Pathway to Class I Guideline (Graphic: Business Wire) The two-arm trial will compare the benefits of HRPCI with Impella versus HRPCI without Impella support. The primary endpoint of the study is the composite of all-cause deat
Blackstone Hires Paul Morrissey to Lead European Investing for Blackstone Growth (BXG)15.4.2021 13:30:00 CEST | Press release
Blackstone (NYSE: BX) today announced that it has hired Paul Morrissey, a seasoned investment professional with extensive private equity and venture capital experience, as a Managing Director to lead investing across Europe for Blackstone Growth (BXG). This newly created role will see Mr. Morrissey manage the European deployment for BXG, which recently completed the final close of its oversubscribed, inaugural $4.5 billion growth equity fund – the largest first-time growth equity private vehicle ever raised. BXG has already made significant investments in fast-growing European companies, including Epidemic Sound, which delivers restriction-free music to internet content creators across the globe, and oat milk pioneer, Oatly. Jon Korngold, Global Head of Blackstone Growth, said: “I’m delighted that Paul has joined us to lead BXG in Europe. Paul is a world-class growth equity investor and his appointment underlines Blackstone’s already-strong commitment to partnering with fast-growing Eu
Bank of America Reports First-Quarter 2021 Financial Results15.4.2021 12:04:00 CEST | Press release
Bank of America reported its first-quarter 2021 financial results today. The news release, supplemental filing and investor presentation can be accessed in the following ways: This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210415005486/en/ Bank of America newsroom at https://newsroom.bankofamerica.comQ1-21 Bank of America Financial Results Press ReleaseQ1-21 Bank of America Investor Relations PresentationQ1-21 Bank of America Supplemental Information Bank of America Investor Relations website at https://investor.bankofamerica.com Business Wire’s news webpage at http://www.businesswire.com/portal/site/home/news Investor Conference Call information: Chief Executive Officer Brian Moynihan and Chief Financial Officer Paul Donofrio will discuss the financial results in a conference call at 9 a.m. ET today. For a listen-only connection to the conference call, dial 1.877.200.4456 (U.S.) or 1.785.424.1732 (international), and the co
REPLY: The Creative Challenge 2021, Organized by Reply, Kicks off in Search of the Creative Talents of Tomorrow15.4.2021 12:02:00 CEST | Press release
Reply announces the opening of registrations for the https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fchallenges.reply.com%2Ftamtamy%2Fchallenges%2Fcategory%2Fcreative&esheet=52411638&newsitemid=20210415005479&lan=en-US&anchor=Creative+Challenge+2021&index=1&md5=a7a453e02454ad9f83092e3da17a94e4 Creative Challenge2021, the team-based competition and part of the Reply Challenges program, that brings together students and young creatives from all over the world. The challenge consists of the development of a creative concept, conceived by some of Europe’s most qualified art directors and marketing and communication professionals. In last year's edition, over 6,200 participants between 18 and 29 years old from more than 70 countries answered the call and, split into over 1,000 teams, submitted more than 500 projects. The challenge, which is going to take place online from Friday 21st to Sunday 23rd May, is enriched by the participation of world-renowned partners such as AC
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