European Commission grants marketing authorisation for world’s first subcutaneous formulation of infliximab, Remsima ® SC, for an additional five indications including for use in inflammatory bowel disease and ankylosing spondylitis
Celltrion Healthcare today announced that the European Commission (EC) has granted marketing authorisation for Remsima® (infliximab, CT-P13) subcutaneous (SC) formulation for the treatment of adult patients with ankylosing spondylitis, Crohn’s disease, ulcerative colitis, psoriatic arthritis and psoriasis.1
The approval follows a positive opinion issued by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in June and is based on data from a pivotal study comparing the pharmacokinetics, efficacy and safety of the SC and intravenous (IV) formulations of Remsima® in people with active Crohn’s disease and ulcerative colitis, throughout a 1-year treatment period.2,3 Based on the results of the pivotal study, a 120 mg fixed dose of Remsima® SC has been approved for use in the European Union (EU), in adults regardless of body weight, in both existing and newly added indications.
Professor Stefan Schreiber, Director of the Clinic for Internal Medicine at Kiel Campus of the University Hospital Schleswig-Holstein in Germany said: “The subcutaneous formulation of Remsima® (Remsima® SC) has been shown to have very high efficacy, and favourable data, which are fully comparable to the efficacy and safety profile of the IV formulation. Today’s approval marks an important progress for the gastroenterology community as it means that treatment can now be administered in significantly less time, thereby providing patients more flexibility and control over how they receive their treatment.”
“We are pleased to announce this important regulatory milestone earlier than we expected, with the European Commission prioritising review of this important new administration option. We will accelerate the launch process on a country-by-country basis in order to expand treatment options for patients with chronic inflammatory diseases such as inflammatory bowel disease and ankylosing spondylitis,” said Hyoung-Ki Kim, Vice Chairman at Celltrion Healthcare. “We will do our best to make Remsima® SC available as early as possible and hope this medication will contribute to minimising the risks involved with administering medical treatments during the COVID-19 pandemic.”
Celltrion anticipates receiving approval of Remsima® SC in 97 countries, including 31 countries in Europe.
-- 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) formulation4,5
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 94 countries (as of July 2020) 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
Forward-looking statement disclaimer
Certain information set forth in this press release contains statements related to our future business and financial performance, and future events or developments involving Celltrion Healthcare, that may constitute forward-looking statements, under pertinent securities laws.
These statements may be identified by words such as “will”, “has potential to”, “brings”, “if approved”, “would”, “could”, “opportunity”, “hope”, “is considering” the negative of these words or such other variations thereon or comparable terminology.
In addition, our representatives may make oral forward-looking statements. Such statements are based on the current expectations and certain assumptions of Celltrion Healthcare's management, of which many are beyond its control.
Forward-looking statements are provided to allow potential investors the opportunity to understand management’s beliefs and opinions in respect of the future so that they may use such beliefs and opinions as one factor in evaluating an investment. These statements are not guarantees of future performance and undue reliance should not be placed on them.
Such forward-looking statements necessarily involve known and unknown risks and uncertainties, which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or result expressed or implied by such forward-looking statements.
Although forward-looking statements contained in this presentation are based upon what management of Celltrion Healthcare believes are reasonable assumptions, there can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Celltrion Healthcare undertakes no obligation to update forward-looking statements if circumstances or management’s estimates or opinions should change except as required by applicable securities laws. The reader is cautioned not to place undue reliance on forward-looking statements.
1 European Medicines Agency Summary of Product Characteristics (SmPC). Remsima.
2 Reinisch W, et al. A novel formulation of CT-P13 (infliximab biosimilar) for subcutaneous administration: 1-year result from a Phase 1 open-label randomised controlled trial in patients with active Crohn’s disease. European Crohn’s and Colitis Organisation 2019. Abstract no: A-1103.
3 Ben-Horin S, et al. A novel subcutaneous infliximab (CT-P13): 1-year results including switching results from intravenous infliximab (CT-P13) in patients with active Crohn’s disease and ulcerative colitis. Oral presentation (OP24). Presented at ECCO 2020.
4 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.
5 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.
+44 (0) 7506 339043
+44 (0) 7751 116252
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
Amazon Project Zero Launches in Seven New Countries11.8.2020 06:00:00 CEST | Press release
Today, Amazon (NASDAQ: AMZN) announced the expansion of Project Zero to seven new countries - Australia, Brazil, Netherlands, Saudi Arabia, Singapore, Turkey, and the UAE - making it available in 17 countries where Amazon has a store. Project Zero combines Amazon’s advanced technology, machine learning, and innovation with the sophisticated knowledge that brands have of their own intellectual property so we can together drive counterfeits to zero. Launched in 2019, Project Zero builds on Amazon’s long-standing work and investments to ensure that customers always receive authentic goods when shopping on Amazon. Over 10,000 brands – from large, global brands to emerging entrepreneurs including Arduino, BMW, ChessCentral, LifeProof, OtterBox, Salvatore Ferragamo, and Veet – have already enrolled in Project Zero. “Amazon is committed to protecting our customers and the brands we collaborate with worldwide,” said Dharmesh Mehta, Vice President of Worldwide Customer Trust and Partner Support
FINEOS Acquires Limelight Health11.8.2020 02:07:00 CEST | Press release
FINEOS Corporation (ASX:FCL), the global market leader in core systems for life, accident and health insurance, has entered into an agreement to acquire Limelight Health, a leading North American provider of quoting, rating and underwriting solutions for group and voluntary employee benefits, for $75M US. The union will provide an end-to-end SaaS core product suite from quote, rate and underwrite through to billing, policy administration, absence and claims management for the global life, accident, and health industry. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200810005814/en/ Michael Kelly, CEO of FINEOS, said: “We’re delighted to welcome the Limelight Health team and their clients to FINEOS, and we look forward to accelerating our combined growth for the benefit of all of our clients, people and partners. This acquisition delivers more product options for our clients as they accelerate their digital transformations an
IFF Reports Second Quarter 2020 Results; Increases Quarterly Dividend10.8.2020 22:05:00 CEST | Press release
International Flavors & Fragrances Inc. (NYSE: IFF) (Euronext Paris: IFF) (TASE: IFF) reported financial results for the second quarter ended June 30, 2020. Management Commentary "Throughout the COVID-19 pandemic, we have continued to serve the needs of our customers and our communities around the world,” said Andreas Fibig, IFF Chairman and CEO. “Our unwavering dedication and commitment through this challenging set of circumstances are indicative of the passion and perseverance of our employees and the resiliency of our business. "The second quarter coincided with peak COVID-19 regulatory actions to date around the world – presenting both opportunities and challenges for our business. We are fortunate that a large portion of our business is in end-markets such as packaged food, beverage, hygiene and disinfection products, all of which have performed well. As we communicated in early June, the categories most exposed to COVID-19 restrictions – Fine Fragrance and Food Service – did expe
CyberArk Named a Leader in Gartner 2020 Magic Quadrant for Privileged Access Management10.8.2020 17:09:00 CEST | Press release
CyberArk (NASDAQ:CYBR), today announced it was named a Leader in the Gartner 2020 Magic Quadrant for Privileged Access Management1, positioned both highest in ability to execute and furthest in completeness of vision for the second time in a row. CyberArk delivers the most comprehensive solution for protecting privileged accounts, credentials and secrets associated with humans, applications and machines across cloud and hybrid environments. As the global leader in privileged access management, CyberArk enables organizations of all sizes to reduce risk, improve operational efficiency and securely adopt modern technologies and infrastructure, including cloud, DevOps and process automation, to transform their business. “This report reinforces that the privileged access management market continues to mature with accelerated adoption,” said Marianne Budnik, CMO, CyberArk. “With privileged access management as its foundation, CyberArk’s Identity Security strategy delivers innovative solution
Silicon Mitus Starts Mass-Producing Automotive OLED PMIC10.8.2020 16:00:00 CEST | Press release
Silicon Mitus, Inc. (Silicon Mitus), an advanced specialist in Power Management Integrated Circuit (PMIC), announced that it has completed the development of automotive OLED PMIC and starts supplying the new products in the global automotive market. Silicon Mitus develops and supplies OLED PMIC with a Korean OLED display manufacturer, which are applied to OLED displays, smartphones, tablets, and laptop computers. Through the addition of the new automotive OLED PMIC, the company is expanding the scope of its business. The automotive OLED PMIC, which Silicon Mitus has started mass-production, is certified with AEC Q100, a standard for automotive semiconductor reliability assessment. Silicon Mitus supplies the OLED PMIC for Virtual Mirror that consists of a camera and an OLED screen to German automakers through global module manufacturers. It also supplies the product for Center Information Display (CID), a screen showing vehicle information inside an automobile, to Japanese automakers. O
Prumo, bp and Siemens Enter Into Partnership With SPIC on Energy Projects in Brazil10.8.2020 15:00:00 CEST | Press release
Prumo, a private Brazilian company controlled by EIG Global Energy Partners, bp and Siemens signed a binding agreement with SPIC Brasil. Under the agreement, SPIC will initially acquire 33% of the GNA I and GNA II LNG-to-power projects, located in Port of Açu, Rio de Janeiro. SPIC has also entered into an agreement to participate in the future expansion projects GNA III and GNA IV, which are expected to be fueled by a combination of LNG and domestic gas from Brazil’s vast pre-salt reserves. The closing of the agreement, scheduled for the fourth quarter of 2020, is subject to the fulfillment of certain conditions precedent usual to this type of transaction, among others. GNA I and GNA II is the largest gas-to-power project in Latin America, with 3 GW of installed capacity — enough to supply energy for up to 14 million households. The complex also includes an LNG terminal with a total capacity of 21 million m3/ day. GNA I, which has an installed capacity of 1.3 GW, is expected to commenc
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