Business Wire

Data Published in The Lancet Shows that CT-P13 is Non-inferior to Reference Infliximab in Inflammatory Bowel Disease

Del

Celltrion Healthcare announced today that The Lancet has published the full data-set from its randomised controlled trial (RCT) of CT-P13 (biosimilar infliximab) in Crohn’s disease (CD), the PLANETCD Study. Results from the phase III study demonstrated the non-inferiority of CT-P13 to reference infliximab in biologic-naïve patients with moderate-to-severe CD.1

CT-P13 is already approved for the treatment of eight autoimmune diseases including CD, a form of inflammatory bowel disease (IBD), in more than 80 countries including the US, Canada, Japan and throughout Europe. This follows EMA approval in 2013 and FDA approval in 2016.

As per regulatory guidelines, approval of CT-P13 was based on proof of biosimilarity versus reference infliximab collected in clinical studies in patients with ankylosing spondylitis and rheumatoid arthritis that established equivalence of the drugs in pharmacokinetics (PK) and efficacy, as well as comparability in safety and immunogenicity.2 ,3 ,4 ,5 ,6 ,7 Approval of CT-P13 in IBD and other non-rheumatological indications was based on extrapolation, a process that allows approval of a biosimilar in a non-studied indication based on the totality of evidence.8, 9,10

These positive results from the CD RCT, build on the existing body of evidence in favour of CT-P13 and validate the extrapolation process on which the approval of CT-P13 was based on for the treatment of IBD.

“This is the first head-to-head study demonstrating the equal efficacy of an anti-TNF biosimilar in inflammatory bowel disease. The findings demonstrate that patients living with Crohn’s disease continue to experience comparable efficacy, pharmacodynamics, pharmacokinetics, safety and immunogenicity when switched to CT-P13 from reference infliximab. This robust evidence makes a compelling case for the use of biosimilars and will inform decision-making by gastroenterologists when choosing anti-TNF therapy for their patients,” said Professor Stefan Schreiber, Director of the Clinic for Internal Medicine at Kiel Campus of the University Hospital Schleswig-Holstein in Germany.

The 54-week RCT, involving 220 patients from 58 centres in 16 countries, showed comparable efficacy and safety profiles between all treatment groups (switched or continued groups) in patients with CD who had failed and/or were intolerant to non-biologic treatments.1

The study used the Crohn’s Disease Activity Index (CDAI), a measurement used to quantify the symptoms of CD patients in order to define response or remission of disease. The primary endpoint was set as the proportion of patients achieving a decrease of ≥ 70 points in CDAI from baseline to week 6. Non-inferiority of CT-P13 to reference infliximab with respect to response rates was established when the 95% confidence interval (CI) between the two drugs fell within the pre-specified margin.1

Mr Hyoung-Ki Kim, Vice Chairman at Celltrion Healthcare said: “The PLANETCD study is the first investigation of the therapeutic efficacy of an infliximab biosimilar powered to show non-inferiority to reference infliximab in inflammatory bowel disease. We at Celltrion Healthcare are proud to be the company leading the way in the biosimilar space as well as witness the growing recognition attributed to our products due to their high quality and cost effectiveness. This PLANETCD study published in The Lancet, together with the evidence from the influential NOR-SWITCH study, which was performed across multiple indications, support the equivalence between CT-P13 and reference infliximab.”

--- Ends---

Notes to editors:

Additional quotes from physicians about the PLANETCD Study

“The study confirmed the validity of extrapolation for CT-P13 and add to the body of evidence supporting its use in patients with IBD,” said Professor Young Ho Kim, a global principal investigator of the study and professor of Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea. “The non-inferior efficacy of CT-P13, measured by CDAI-70 response, was demonstrated as a primary endpoint after week 6, and comparable response rates were maintained up to week 54. Both efficacy and safety profiles were observed to be similar in all study arms including switching groups for a year.”

About inflammatory bowel disease

Inflammatory bowel diseases (IBD), including Crohn’s disease (CD) and ulcerative colitis (UC), are chronic disabling gastrointestinal disorders that impact every aspect of a patient’s life.11 They affect an estimated 5 million people globally;12 IBDs account for substantial costs to the healthcare system and society; the direct healthcare costs of IBDs are estimated to be €4.6-5.6 billion per year.13

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 March 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/

About The Lancet medical journal

The Lancet is the world's leading independent general medical journal. The journal's coverage is international in focus and extends to all aspects of human health. The Lancet publishes the original primary research and review articles of the highest standard. The Lancet is stringently edited and peer-reviewed to ensure the scientific merit and clinical relevance of its diverse content. Drawing on an international network of advisers and contributors, The Lancet meets the needs of physicians by adding to their clinical knowledge and alerting them to current issues affecting the practice of medicine worldwide. The Lancet has an Impact Factor of 53.254.14

References

1 Byong Duk Y, et al. Efficacy and safety of biosimilar CT-P13 compared with innovator infliximab in patients with active Crohn’s disease: An international, randomised, double blind, parallel-group, non-inferiority phase III study, The Lancet. Available at http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(18)32196-2/fulltext [Last accessed March 2019]
2 Yoo DH, et al. A randomised, double-blind, parallel-group study to demonstrate equivalence in efficacy and safety of CT-P13 compared with innovator infliximab when co-administered with methotrexate in patients with active rheumatoid arthritis: the PLANETRA study. Ann Rheum Dis. 2013;72(10):1613-20.
3 Yoo DH, et al. A phase III randomized study to evaluate the efficacy and safety of CT-P13 compared with reference infliximab in patients with active rheumatoid arthritis: 54-week results from the PLANETRA study. Arthritis Res Ther. 2016;18:82.
4 Yoo DH, et al. Efficacy and safety of CT-P13 (biosimilar infliximab) in patients with rheumatoid arthritis: comparison between switching from reference infliximab to CT-P13 and continuing CT-P13 in the PLANETRA extension study. Ann Rheum Dis. 2017;76(2):355-363.
5 Park W, et al. A randomised, double-blind, multicentre, parallel-group, prospective study comparing the pharmacokinetics, safety, and efficacy of CT-P13 and innovator infliximab in patients with ankylosing spondylitis: the PLANETAS study. Ann Rheum Dis. 2013;72(10):1605-12.
6 Park W, et al. Comparable long-term efficacy, as assessed by patient-reported outcomes, safety and pharmacokinetics, of CT-P13 and reference infliximab in patients with ankylosing spondylitis: 54-week results from the randomized, parallel-group PLANETAS study. Arthritis Res Ther. 2016;18:25.
7 Park W, et al. Efficacy and safety of switching from reference infliximab to CT-P13 compared with maintenance of CT-P13 in ankylosing spondylitis: 102-week data from the PLANETAS extension study. Ann Rheum Dis. 2017;76(2):346-354.
8 Jung SK, et al. Physiochemical characterization of Remsima. MAbs 2014; 6: 1163-77.
9 United States Food and Drug Administration. CT-P13 (infliximab biosimilar) briefing document for the arthritis advisory committee. February 2016. Available from: https://www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials/drugs/arthritisadvisorycommittee/ucm484860.pdf [Last accessed March 2019]
10 European Medicines Agency. Assessment report: Remsima. June 2013. EMA/CHMP/589317/2013. Available from: https://www.ema.europa.eu/documents/assessment-report/remsima-epar-public-assessment-report_en.pdf [Last accessed March 2019]
11 Molodecky NA, et al. Increasing incidence and prevalence of the inflammatory bowel diseases with time, based on systematic review. Gastroenterology. 2012; 142(1)46–54. Available at www.gastrojournal.org/article/S0016-5085 (11)01378-3/pdf [Last accessed March 2019]
12 The European Federation of Crohn’s & Ulcerative Colitis Associations. What is IBD? Science. Available at:  www.efcca.org/en/science [Last accessed March 2019]
13 Burisch J, et al. The burden of inflammatory bowel disease in Europe. Journal of Crohn's and Colitis (2013)7,322-337.
14 The Lancet, Available at: https://www.journals.elsevier.com/the-lancet [Last accessed March 2019]

Contact information

Emma Gorton
egorton@hanovercomms.com
+44 203 817 6791

Preetika Ramjoorawon
pramjoorawon@hanovercomms.com
+44 203 817 6718

Om Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

(c) 2018 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

Følg saker fra Business Wire

Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.

Siste saker fra Business Wire

 Avioq Announces CE Mark and European Launch of VioOne HIV Profile Supplemental Assay24.6.2019 15:11:00 CESTPressemelding

Avioq, Inc. has received CE Marking (Conformité Européenne) and has begun marketing their VioOne™ HIV Profile™ Supplemental Assay in the European Union and other CE Mark countries. The product has also been submitted for FDA approval. “We are pleased to provide the CE Mark HIV Profile™ assay to countries outside the U.S.,” said Chamroen Chetty, CEO of Avioq. Dr. Chetty continues, “We are also looking for distribution partners to expand the global availability.” The HIV Profile™ is an enzyme-linked immunosorbent assay (ELISA) for confirmation and differentiation of individual antibodies directed to various gene products of HIV-1 (Group M & Group O) and HIV-2 in human serum or plasma that were repeatedly reactive in diagnostic screening procedures. Results can also be used to distinguish recent from longstanding HIV-1 infection for HIV-1 incidence estimation. About Confirmatory Testing In 2014, the CDC released a new algorithm for HIV testing. The second step of the algorithm includes a

Global Launch of S BLOCK, Kicked Off in Singapore on June 22nd24.6.2019 12:29:00 CESTPressemelding

The globally renowned 2019 WBF Singapore Technology Conference was held in Marina Bay Sands Hotel on June 22nd, 2019. S BLOCK, the conference co-host, unveiled itself and announce its mission to “Unleash your digital assets” for the first time. The conference brought together numerous industry elites and blockchain enthusiasts from all around the world, including more than 500 industry veterans from over 30 countries, such as Switzerland, Germany, France, Russia, Japan, Korea, Brazil, Australia, Argentina and Canada. Insiders shared profound global industry insights. This conference draws great attention from across the global blockchain industry. S BLOCK Kicked Off in Singapore In the morning of June 22nd, Ivan - President of S BLOCK Global Foundation, was invited to deliver a keynote speech, “Next Generation Digital Currency Wallet”. At this conference, S BLOCK was officially launched in more than 30 countries around the world, and opened up the way to a global future without borders

SpeeDx announce a collaborative agreement with GSK to supply tests and technology24.6.2019 12:00:00 CESTPressemelding

SpeeDx Pty. Ltd., a developer of innovative molecular diagnostic solutions, has signed a collaborative agreement with GSK, to provide a combination of existing tests and custom test development to support certain GSK antibiotic clinical trials and new product development. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190624005302/en/ “SpeeDx has a demonstrated commitment to improve patient care, and our tests currently used in clinical practice are supporting Resistance Guided Therapy, positively impacting cure rates and helping to minimise the spread of antimicrobial resistant infections.” Colin Denver, SpeeDx CEO. (Photo: Business Wire) “We welcome this extension of the utility and application of our tests and technology,” said Colin Denver, SpeeDx CEO. “SpeeDx has a demonstrated commitment to improve patient care, and our tests currently used in clinical practice are supporting Resistance Guided Therapy, positively impac

Nexon Computer Museum to Hold the Fourth VR Content Contest24.6.2019 10:13:00 CESTPressemelding

Nexon Computer Museum (NCM) of NXC is holding the fourth virtual reality content contest, ‘2019 NCM OPEN CALL X REALITY’. NXC is a holding company of Nexon (TOKYO: 3659). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190624005284/en/ Nexon Computer Museum (NCM) of NXC is holding the fourth virtual reality content contest 2019 NCM OPEN CALL X REALITY with total prize money of KRW 13 million. Application received from July 1st to August 31st, winners announced on October 25th. (Graphic: Business Wire) NCM OPEN CALL is an exhibit to discover and support virtual reality content creators. This year’s keyword ‘X REALITY’ encompasses all kinds of virtualization including VR, AR, MR, and more. It also implies eXtended Reality, which broadens the perspectives of reality, and Cross Reality, which overlaps the real and virtual world. The unpredictable X signifies NCM OPEN CALL’s pursuit towards embracing various kinds of innovative an

REPLY: New Tool “China Beats” Provides Deep Insights Into the Chinese Market24.6.2019 09:15:00 CESTPressemelding

TD Reply, the company specializing in marketing and innovation consulting within the Reply Group, developed China Beats, a business intelligence solution that enables companies to gain an in-depth understanding of the Chinese market and its players. This is ensured by AI-supported social listening with connection to all major Chinese e-commerce, social media and search platforms such as Alibaba, Baidu, WeChat and Weibo. The prosperity of the Chinese population is growing at a rapid pace. According to analysts estimates, around 550 million Chinese will belong to the middle class by 2022. As a result, the Chinese market is also becoming increasingly important for international companies. Entering the market, however, is challenging, especially in terms of reliable identification of target groups, analysis of their consumer behavior and preferences. Digital data can provide a remedy, because the majority of Chinese consumers are netizens who shop on digital platforms, exchange their opini

MYbank Works With Financial Institution Partners to Serve Over 15 Million SMEs24.6.2019 05:42:00 CESTPressemelding

MYbank, a leading online private commercial bank in China with a focus on SME financing, today announced that the bank’s Star Plan has enabled MYbank, with its financial institution partners, to serve over 15 million small and micro enterprises (SMEs). SMEs are key drivers of economic growth and this partnership is now serving more SMEs than any other in the world. The announcement comes on the day that MYbank celebrates its 4th Anniversary. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190623005055/en/ MYbank’s 310 lending model enables inclusive finance for SMEs in China (Photo: Business Wire) MYbank’s Star Plan was announced on June 21, 2018 with the aim of using technology to enable 1,000 financial institution partners to provide more cost-effective financing services to 30 million SMEs in China within a three-year period. A little over a year later and the Star Plan is showing significant progress. As of June 2019, lev