CELLTRION
Celltrion Healthcare today presented new findings at the Annual European Congress of Rheumatology (EULAR 2019) from a two-part study investigating the pharmacokinetics, efficacy and overall safety of CT-P13 SC in patients with RA during the treatment period of one year. The second part of the study demonstrated the non-inferiority of the efficacy and compared safety profiles of CT-P13 SC to CT-P13 IV in people with RA over 30 weeks.
Part one of the study enrolled 50 patients of which 48 patients were randomly assigned at week six into four cohorts in a 1:1:1:1 ratio. The IV cohort received CT-P13 IV 3mg/kg every eight weeks and the SC cohorts received CT-P13 SC 90mg, 120mg or 180mg, respectively, every two weeks up to week 54. Overall, the efficacy results of CT-P13 SC up to week 54 were comparable to those of CT-P13 IV. Disease improvement was assessed using the DAS28 (CRP), a disease activity score, and ACR20 score for RA. Results demonstrated that DAS28 (CRP) and ACR20 were comparable across all four cohorts, regardless of the route of administration or dosage of CT-P13. The safety profiles at week six in CT-P13 SC were comparable to CT-P13 IV and were similar to those previously reported for IV infliximab.1
This study was followed by a phase I/III randomised controlled trial. A total of 362 RA patients were enrolled, of whom 348 were randomised at week six into two treatment arms in a 1:1 ratio (169 and 179 patients in SC 120mg bi-weekly or IV 3mg/kg arms every 8 weeks, respectively). The aim of the study was to compare the safety profiles and demonstrate the non-inferiority of efficacy of CT-P13 SC and CT-P13 IV in people with RA over 30 weeks. The trial showed that the mean change of DAS28 (CRP) from baseline to week 22 was similar between the two arms. The lower limit of the 95% CI (0.03) for the treatment difference in the change of DAS28 (CRP) from baseline was greater than the pre-specified non-inferiority margin (-0.6) indicating non-inferiority of CT-P13 SC compared to CT-P13 IV. ACR responses were also similar between the two treatment arms up to week 22. The safety profile at week six in the SC 120mg arm was comparable to the IV 3mg/kg arm.2
Professor Rieke Alten, Head of the Department of Internal Medicine, Rheumatology, Clinical Immunology and Osteology at Schlosspark-Klinik, Teaching Hospital of Charité, Berlin, Germany said, “Despite improvements in treating RA, there is still a significant way to go to help patients and reduce the burden of the disease. Today, pain, fatigue and the psychological issues connected with RA really impact patients on a daily basis, and with frequent visits to hospitals, it is crucial that we find an effective treatment option for patients. The SC formulation of biosimilar infliximab, CT-P13, could address unmet needs in maintenance therapy and provide an affordable, convenient, and personalised treatment option. The results seen to-date demonstrate CT-P13 SC has the potential to be an innovative biosimilar treatment – improving convenience and allowing patients to have more control of their treatment and enjoy life again.”
In a separate study, Celltrion investigated the long-term safety and efficacy of CT-P13 up to five years in people with RA and ankylosing spondylitis (AS), including patients who switched from reference infliximab to CT-P13. The study collected and analysed data from 491 patients (154 RA and 337 AS), including 19 and 118 switched patients with RA and AS, respectively. The probability of drug survival at year five for patients with RA was 0.42 and 0.53, respectively for naïve and switched patients. The probability of drug survival at year five for patients with AS was 0.64 and 0.72, respectively for naïve and switched patients. This five-year analysis of medical records showed that long term treatment with CT-P13 was safe and efficacious based on drug survival, disease activity measurements and adverse events. Drug survival was similar between patients who were naïve at the start of CT-P13 treatment and switched from reference to CT-P13.
Mr Hyoung-Ki Kim, Vice Chairman at Celltrion Healthcare said, “We at Celltrion Healthcare are proud to be leading in the biosimilar space, providing physicians with accessible treatment options that suit the individual needs and preferences of their patients, whether that is intravenous or subcutaneous, is important to us. Such innovations in drug administration are shown to really benefit patients and so, being able to offer CT-P13 SC, with the new pharmaco-economic value expected with dual formulation of infliximab, could offer patients a more convenient treatment option reducing the time spent in hospitals.”
+++
Notes to Editors
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
rheumatoid arthritis 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 89
countries (as of May 2019) 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 endeavors to offer high-quality cost-effective solutions
through an extensive global network that spans more than 120 different
countries. For more information please visit: http://www.celltrionhealthcare.com/
1
Yoo DH, 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 Presented at the Annual
European Congress of Rheumatology (EULAR 2019).
2
Westhovens R, 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 Presented at the Annual European Congress of
Rheumatology (EULAR 2019).
View source version on businesswire.com: https://www.businesswire.com/news/home/20190611005468/en/
Contact:
Emma Gorton egorton@hanovercomms.com +44 203 817 6791
Preetika Ramjoorawon pramjoorawon@hanovercomms.com +44 203 817 6718
Link:
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
The Coca-Cola Company Names New Leader for Europe Operating Unit18.7.2025 21:00:00 CEST | Press release
The Coca-Cola Company today announced that Luisa Ortega will become president of the Europe operating unit effective Sept. 1, succeeding Nikos Koumettis, who will retire in 2026 after a 25-year career with the company. Koumettis will remain with the company through Feb. 28, 2026, as a senior advisor. He will also serve on the board of directors of Hindustan Coca-Cola Beverages Pvt. Ltd., a company-owned bottler in India. Ortega joined Coca-Cola in 2019 and currently serves as president of the Africa operating unit. In this role, she leads a complex business that operates across 54 markets. Koumettis has led the Europe operating unit since it was created in 2021. “Luisa has done an outstanding job leading our African business, where our system has continued to make major investments to serve growing markets on the continent,” said Henrique Braun, Executive Vice President and Chief Operating Officer of The Coca-Cola Company. “As head of Europe, she will bring great international experien
NFL Running Back Derrick Henry Joins Amazfit as Athlete Ambassador18.7.2025 15:00:00 CEST | Press release
Henry to utilize Amazfit products to optimize health, recovery and performance as he enters his 10th NFL season Amazfit, a leading global smart wearables brand owned by Zepp Health (NYSE: ZEPP), announced Baltimore Ravens running back Derrick Henry as the newest elite athlete to join its growing roster of ambassadors. Known for his rare combination of speed and strength, Henry will utilize Amazfit wearables to power every phase of his training, recovery and sleep as he prepares for his 10th NFL season. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250718322498/en/ Derrick Henry is the newest elite athlete to join Amazfit's growing roster of ambassadors. As one of the most prolific running backs of his generation, Henry has amassed an impressive array of accolades during his career, including NFL Offensive Player of the Year, two rushing titles, and five Pro Bowl selections. With Amazfit as his official smart wearable partne
Qualcomm Announces Quarterly Cash Dividend18.7.2025 15:00:00 CEST | Press release
Qualcomm Incorporated (NASDAQ: QCOM) today announced a quarterly cash dividend of $0.89 per common share, payable on September 25, 2025, to stockholders of record at the close of business on September 4, 2025. About Qualcomm Qualcomm relentlessly innovates to deliver intelligent computing everywhere, helping the world tackle some of its most important challenges. Building on our 40 years of technology leadership in creating era-defining breakthroughs, we deliver a broad portfolio of solutions built with our leading-edge AI, high-performance, low-power computing, and unrivaled connectivity. Our Snapdragon® platforms power extraordinary consumer experiences, and our Qualcomm Dragonwing™ products empower businesses and industries to scale to new heights. Together with our ecosystem partners, we enable next-generation digital transformation to enrich lives, improve businesses, and advance societies. At Qualcomm, we are engineering human progress. Qualcomm Incorporated includes our licensin
MultiBank Group Confirms $MBG Token Listings on MEXC and Gate.io on TGE Day in Addition to MultiBank.io and Uniswap18.7.2025 14:34:00 CEST | Press release
MultiBank Group, the world’s largest & most regulated financial derivatives institution, is proud to announce that its highly anticipated $MBG Token will be listed on two new major global cryptocurrency exchanges — MEXC and Gate.io — on the day of its official Token Generation Event (TGE), July 22, 2025, in addition to MultiBank.io and Uniswap. The $MBG Token will go live on: MultiBank.ioGate.ioMEXCUniswap This new dual listing will allow millions of users across both exchanges to seamlessly access and trade $MBG using their existing accounts, ensuring immediate market participation at launch. The Token Generation Event (TGE) is now approaching following the successful completion of two pre-sale rounds, where MultiBank Group issued 7 million tokens in Round 1 and 3 million tokens in Round 2 — both of which sold out within minutes. Naser Taher, Chairman and Founder of MultiBank Group said “With $MBG, we’re introducing a utility token built to deliver real-world value, transparency, and
SLB Announces Second-Quarter 2025 Results18.7.2025 12:50:00 CEST | Press release
Revenue of $8.55 billion increased 1% sequentially and decreased 6% year on year GAAP EPS of $0.74 increased 28% sequentially and decreased 4% year on year EPS, excluding charges and credits, of $0.74 increased 3% sequentially and decreased 13% year on year Net income attributable to SLB of $1.01 billion increased 27% sequentially and decreased 9% year on year Adjusted EBITDA of $2.05 billion increased 2% sequentially and decreased 10% year on year Cash flow from operations was $1.14 billion and free cash flow was $622 million Board approved quarterly cash dividend of $0.285 per share SLB (NYSE: SLB) today announced results for the second-quarter 2025. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250716727689/en/ The exterior of the SLB headquarters in Houston, Texas. Second-Quarter Results(Stated in millions, except per share amounts)Three Months EndedChangeJun. 30, 2025Mar. 31, 2025Jun. 30, 2024SequentialYear-on-yearReve
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