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
Andersen Global Initiates Expansion into Albania28.10.2020 14:30:00 CET | Press release
Andersen Global continues to focus on its expansion strategy in the European region with the addition of KALO & ASSOCIATES in Albania. The firm, founded in 1994 by Managing Partner Perparim Kalo, is a leading law firm in Albania. With a team of eight Partners and 30 professionals, the firm has proven capabilities in banking and finance, corporate, commercial litigation and arbitration, employment, tax, infrastructure, intellectual property, and real estate. In addition to working with large projects and investors and IFIs, including a number of Fortune 500 companies, the firm has contributed to the development of a modern commercial legislation and regulatory framework through involvement in the drafting of laws on secured transactions, financial leasing, pension funds, collective investment funds, telecommunications, concessions, renewable energy and energy efficiency. Additionally, the firm is highly ranked by IFLR1000,Chambers and Legal 500. “As the business environment continues to
Sevan Completes 28,000 Surveys, Reaches Major Milestone28.10.2020 14:00:00 CET | Press release
Sevan Multi-Site Solutions, Inc. (Sevan) — a global leader in innovative design, program management, construction services and data analytics — has reached a significant milestone. The company has completed 28,000surveys, adding up to more than 700 million square feet since Sevan’s inception in 2011. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201028005437/en/ Sevan completes 28,000 surveys, reaches major milestone. More than 700 million square feet surveyed. (Graphic: Business Wire) “Sevan’s surveys have become a thread that runs through many of our program management offerings,” President and CEO Jim Evans said. “One of our strongest traits as a company is that we tailor to the needs of our clients, customize innovative solutions and deliver excellence. It has been incredible to see the growth of our surveys and technology offerings in the past years, and we are grateful we have the opportunity to contribute to the succ
Synergis Adept Named #1 in 21 Rankings on G2’s 2020 Fall Grid Reports28.10.2020 13:21:00 CET | Press release
Synergis Software, a global leader in engineering information management and product data management (PDM), today announced that its flagship product, Adept, has earned 21 top placements in G2 Crowd’s Fall 2020 Grid Reports. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201028005422/en/ Synergis Adept earns 21 top honors on G2 Crowd's 2020 Fall Grid Reports. (Graphic: Business Wire) The reports, which are based on real customer reviews, highlight Adept’s leadership in ease of use, ease of setup, fastest implementation, best support and best relationship as some of the key differentiators compared to other products on the market. Adept earned Leader status in Product Data Management (PDM) and Enterprise Content Management (ECM), and High Performer status in Construction Drawing Management. “We're committed to helping clients become more efficient, secure and collaborative, and reports like this help us understand what we're
Boehringer Ingelheim Begins Phase 2 Clinical Trial of a Targeted Therapy to Help People with Severe Respiratory Illness from COVID-1928.10.2020 13:20:00 CET | Press release
Boehringer Ingelheim today announced the initiation of a Phase 2 clinical trial of BI 764198, an inhibitor of TRPC6, a receptor-operated cation channel. This potent and selective inhibitor of TRPC6 may alleviate the damage to the lung and decrease the risk or severity of acute respiratory complications in patients hospitalized for COVID-19. The aim of therapy with BI 764198 is to reduce the need for ventilator support, to improve patient recovery rate and ultimately to save lives. Boehringer Ingelheim is committed to fighting COVID-19 and contributing with its expertise and resources to develop new therapeutic options for patients suffering from the virus’ severe complications. “COVID-19 can cause serious lung complications, such as viral pneumonia, and in severe cases can lead to acute respiratory distress syndrome (ARDS) and lung failure,” said Dr. Lorraine B. Ware, Ralph and Lulu Oven Endowed Chair and Professor of Medicine, and Pathology, Microbiology and Immunology, Vanderbilt Uni
First Patients Treated with the World’s Smallest Heart Pump, the 9Fr Impella ECP28.10.2020 13:03:00 CET | Press release
Abiomed (NASDAQ: ABMD) announces the first two patients have been treated with the Impella ECP expandable percutaneous heart pump. Impella ECP is the smallest heart pump in the world. It measures 9 French (Fr) (3 millimeters) in diameter upon insertion and removal from the body. While in the heart, it expands while supporting the heart’s pumping function, providing peak flows greater than 3.5 L/min. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201028005398/en/ Impella ECP is the world’s smallest heart pump. (Graphic: Business Wire) The first Impella ECP patient was treated by Amir Kaki, MD, an interventional cardiologist and director of mechanical circulatory support at Ascension St. John Hospital in Detroit, part of Ascension Michigan. The patient had severe narrowing of his coronary arteries. Dr. Kaki successfully opened the patient’s arteries by performing several percutaneous interventions with support from Impella ECP
Alira Health and Embleema Announce Partnership to Deploy Next-Generation Real-World Data Solutions for Life Sciences28.10.2020 13:00:00 CET | Press release
Alira Health, a leading international healthcare and life sciences advisory firm, and Embleema, the innovative software provider for patient-driven healthcare data platforms, today announced a strategic partnership to develop next-generation real-world data solutions aimed at accelerating clinical innovation and improving patient outcomes. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201028005026/en/ "Our partnership with Embleema is a critical step in the further development of our real-world evidence capabilities, which connects clinical research, hospital care, and the patient experience,” says Gabriele Brambilla, Chief Executive Officer of Alira Health. Romain Finas, VP of Real World Evidence at Alira Health, adds, “We are excited to offer our clients new solutions for real-world data, which will empower them to better evaluate their treatments and deliver new innovations to patients more quickly.” Robert Chu, Chief Ex
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