INCHEON, South Korea, June 9, 2015 /PRNewswire/ --

Expanding clinical experience with biosimilar infliximab CT-P13

The comparable safety and efficacy of switching patients to a biosimilar anti-TNF-α monoclonal antibody from the reference medicinal product (RMP) has been further established in data presented at the European League Against Rheumatism Annual Congress (EULAR 2015). Data from abstracts published or presented at the conference show that the effectiveness of biosimilar infliximab CT-P13, developed and manufactured by Celltrion, Inc., was similar to the RMP in rheumatoid arthritis (RA) and ankylosing spondylitis (AS) patients who were switched from the RMP to the biosimilar infliximab, with no additional safety signals.^[1]

Similar immunogenicity between biosimilar infliximab and the RMP in patients with RA and AS was also demonstrated in another study presented at EULAR 2015.^[2] Professor Jürgen Braun, Professor of Rheumatology at the Free University Berlin and the Ruhr University Bochum, Germany, and lead author of the immunogenicity study,^[2] concluded that "no immunogenic difference between biosimilar infliximab and the RMP was found in two studies of patients with RA or AS."

Switching to biosimilar infliximab from the RMP 

In the study by Sokka et al,^[1] 39 RA and AS patients were switched from the RMP to biosimilar infliximab after a mean (SD) of 4.1 (2.3) years of treatment with the RMP. After a median of 11 (7.5 - 13) months following the first administration of biosimilar infliximab, patients' symptom levels (pain, fatigue, patient global health) and disease activity (doctor global assessment of activity, Health Assessment Questionnaire, and erythrocyte sedimentation rate and C-reactive protein levels) were clinically assessed. The effectiveness of biosimilar infliximab appeared similar to the RMP in patients who switched from the RMP to biosimilar infliximab and no immediate safety signals were observed.^[1]

Intrinsic and extrinsic factors affecting anti-drug antibody (ADA) development 

A retrospective analysis for factors related to immunogenicity was performed using data from the PLANETRA and PLANETAS studies, which have previously demonstrated the biosimilarity of CT-P13 to its RMP. Data from the 852 patients (602 RA and 250 AS patients) in the studies showed similar immunogenicity results during the study period in both trials. The only statistically significant influencing factor was age in the PLANETRA study. Concomitant medication (methotrexate/glucocorticoid) did not appear to have an impact on ADA formation.^[2]

Dr Stanley Hong, President and CEO of Celltrion Healthcare, said: "Once again we see clinical evidence demonstrating the safety and efficacy of biosimilar infliximab and supporting the switchability of the treatment. A cost-effective treatment option like biosimilar infliximab will help to decrease the current and extensive burden on healthcare systems across Europe. These financial pressures can lead to rationing of biologic medicines like anti-TNFs for the treatment of devastating conditions like rheumatoid arthritis and ankylosing spondylitis. We are proud that biosimilar infliximab is available for patients across the European Union, offering them a more accessible treatment option to manage their disease."

A meta-analysis of the safety data for biosimilar infliximab and its RMP showing that the safety profiles of both drugs in patients with RA and AS are consistent has also been reported at EULAR 2015.^[3]

Notes to editors: 

About rheumatoid arthritis and ankylosing spondylitis  

In Europe more than 2.9 million people have rheumatoid arthritis, 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.^[4] Although there is no cure for rheumatoid arthritis, there are many treatments that can reduce inflammation and ease pain. As with all rheumatic diseases early diagnosis and intervention is key.

Ankylosing spondylitis is a rheumatic disease that primarily affects the spine. Around 1.5 million people in Europe have ankylosing spondylitis.^[5] It is five times more frequent in men than women and most cases of ankylosing spondylitis start in people aged 20-30.^[5],[6]

About Remsima® (CT-P13) 

Remsima® is the world's first biosimilar monoclonal antibody to be approved by the European Medicines Agency (EMA) for the treatment of eight autoimmune diseases. It was approved by the EMA under the trade name Remsima® in September 2013 and launched in Europe in early 2015. It is not approved by the U.S. Food and Drug Administration.

About Celltrion Healthcare 

Celltrion Healthcare conducts worldwide marketing, sales, and distribution of biological medicines developed by Celltrion, Inc. through an extensive global network that spans more than 120 different countries, including both developed and emerging markets. Celltrion Healthcare's products are manufactured at state-of-the-art mammalian cell culture facilities, designed and built to comply with the US FDA's cGMP and the EMA's GMP standards. For more information please visit: http://www.celltrionhealthcare.com/

Celltrion Healthcare has established a vast distribution network of partners and experts who have in-depth knowledge and experience in their local markets. In European markets, Celltrion Healthcare is in partnership with the following companies:

• Astro Pharma: Austria
• Biogaran: France and Monaco
• DEMO S.A.: Cyprus
• Egis: Armenia, Azerbaijan, Belarus, Georgia, Kazakhstan, Moldova, Bulgaria, Czech Republic, Latvia, Lithuania, Poland, Romania, Slovakia, Russia, Ukraine, Uzbekistan and Hungary.
• Hospira: Europe

• Kern Pharma: Spain
• Medical Logistics: Malta
• Mundipharma: Belgium, Germany, Italy, Luxembourg, the Netherlands and the UK (Napp)
• Oktal Pharma d.o.o. : Slovenia, Croatia, Bosnia-Herzegovina and Serbia
• Orion: Denmark, Estonia, Finland, Norway, and Sweden
• PharmaKern: Portugal
• Pinewood: Ireland

References 

1. Sokka T and Kautiainen H. Clinical experience with infliximab biosimilar - switch from Remicade. EULAR 2015. SAT0174. 

2. Braun J et al. What intrinsic and extrinsic factors affect the development of anti-drug antibody to innovator infliximab and its biosimilar CT-P13 in rheumatoid arthritis and ankylosing spondylitis. EULAR 2015. FRI0119. 

3. Park et al. Meta-analysis of the safety data between infliximab biosimilar (CT-P13) and innovator infliximab in rheumatoid arthritis and ankylosing spondylitis. EULAR 2015. AB0433.

4. NRAS, European Fit for Work Report. Available at http://www.nras.org.uk/european-fit-for-work-report . [Last accessed June 2015]. 

5. Ankylosing Spondylitis,. Available at http://www.efpia.eu/diseases/110/59/Ankylosing-Spondylitis [Last accessed June 2015].

6. Braun J and Sieper J. Ankylosing spondylitis. Lancet 2007; 369:1379-1390. 

SOURCE Celltrion Healthcare