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Celltrion Healthcare Showcases Promising Preliminary Results for New Subcutaneous Formulation of CT-P13 (biosimilar infliximab) in Patients with Rheumatoid Arthritis

New data presented at the Annual European Congress of Rheumatology (EULAR 2018) show that the subcutaneous (SC) formulation of CT-P13 is comparable in terms of efficacy and safety with the intravenous (IV) formulation of CT-P13 for the treatment of patients with rheumatoid arthritis (RA) up to week 30. The results indicate that CT-P13 SC could be a future alternative infliximab treatment.1

The objective of the randomised, controlled phase I/III study was to evaluate efficacy, pharmacokinetic (PK) properties and the safety profile of CT-P13 SC over the first 30 weeks of treatment and to find the optimal dose of CT-P13 SC.

In the study, patients were randomly assigned into four cohorts; one group receiving CT-P13 IV and the other three receiving different doses of CT-P13 SC (90mg/120mg/180mg) bi-weekly. The initial 30-week results from the study showed comparable efficacy of CT-P13 SC to CT-P13 IV regardless of the route of administration or dosage with similar DAS28 and ACR20 scores - standardised disease improvement measurements for rheumatoid arthritis used to measure disease activity and disease improvement respectively. The safety profiles in CT-P13 SC cohorts were comparable to CT-P13 IV.1

Professor Rene Westhovens, Rheumatologist at the University Hospitals KU Leuven, Belgium said: “These preliminary results are encouraging as they show that CT-P13 SC is safe and has comparable efficacy to the well-established intravenous version. This new injection formulation of infliximab would give patients the opportunity to self-inject, saving their time and giving them more autonomy.”

Mr Hyoung-Ki Kim, Vice Chairman at Celltrion Healthcare said, “At Celltrion Healthcare, our aim is to provide the best possible treatment options for patients and physicians. While the treatment of intravenous CT-P13, an infliximab biosimilar, is effective and well-tolerated, a new SC formulation would provide added patient convenience. Subsequently, based on the positive week 30 results presented today, we are planning to launch CT-P13 SC next year if approved as part of our ‘twin-track’ strategy to create more choice and synergy across the healthcare system.”

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Notes to editors:

About rheumatoid arthritis

In Europe, more than 2.9 million people have rheumatoid arthritis (RA), many of whom are of working age. On average, every third person with RA becomes work disabled and up to 40 per cent leave work completely within 5 years of diagnosis.2 Although there is no cure for RA, there are many treatments that can reduce inflammation and ease pain. As with all rheumatic diseases early diagnosis and intervention is key.

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 87 countries (as of May 2018) 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 Westhovens et al . Novel formulation of CT-P13 for subcutaneous administration in patients with rheumatoid arthritis: Initial results from a phase I/III randomized controlled trial. Annual European Congress of Rheumatology (EULAR). 2018. THU0191

2 NRAS, European Fit for Work Report. Available at www.nras.org.uk/european-fit-for-work-report .

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