Celltrion Healthcare announces its commitment to develop anti-drug antibody and drug concentration assay to enable evidence-based decision-making in a
News follows recent FDA approval of InflectraTM (biosimilar infliximab, other brand name Remsima®), now the first and only biosimilar monoclonal antibody (mAb) approved in the US
INCHEON, REPUBLIC OF KOREA, 5 July 2016 – Celltrion Healthcare, a global biopharmaceutical company, today announced its research commitment to develop laboratory tests that will determine both drug and anti-drug antibody (ADA) levels in the blood, enabling physicians to identify when patients on an anti-tumour necrosis factor (anti-TNF) drug require a change of dose or a switch to a different treatment in the class.
Mr. Man Hoon Kim, President, Celltrion Healthcare said: “Biologics and biosimilars tested with advanced analytical methods to assess drug and ADA levels could be used for developing tailored treatments. Celltrion is fully committed to support this type of research to develop affordable laboratory tests, or kits, for routine monitoring that allows personalized infliximab treatment according to the disease status of individual patients.”
A group of researchers released an observational study in rheumatoid arthritis (RA), the results of which were presented at the recent European League Against Rheumatism annual congress (EULAR 2016).[1] The study assessed the correlation between ADA levels in patients with RA and circulating blood levels of an anti-TNF therapy as a potential predictor of a patient’s response to treatment. The results showed that high levels of ADAs at the beginning of treatment were associated with a poor response at a later stage.
Discussing the results, study investigator Professor Chamaida Plasencia of La Paz University Hospital-Idipaz in Madrid, Spain, said: “Therapeutic drug monitoring is important in patients with chronic inflammatory diseases using biological therapies such as TNF inhibitors. The serum trough levels of TNF inhibitors are closely correlated with clinical efficacy. Several factors are associated with a faster drug clearance including anti-drug antibody formation. Differences in the structure of TNF inhibitors are crucial in terms of drug immunogenicity. Recent evidence demonstrates that drug and/or anti-drug antibody level monitoring at early stages of therapy is correlated with clinical outcomes. Therapeutic drug monitoring could help physicians make evidence-based decisions about treatment, thus avoiding the undesirable consequences of immunogenicity such as treatment failure.”
Celltrion’s ongoing commitment to evidence-based healthcare was also demonstrated by the company’s decision to undertake extension studies of its registration trials up to 102-week: PLANETRA[2] and PLANETAS[3]. Published in Annals of the Rheumatic Diseases in April 2016, the extension studies showed that Remsima® was well-tolerated and effective over two years, and that the efficacy, safety and immunogenicity of Remsima® and the reference medicinal product (RMP) were comparable both in patients who remained on Remsima® and in those who were switched from the RMP.
Mr. Kim added: “Remsima was diversely tested up to 102-weeks for immunogenicity; 3mg/kg and 5mg/kg, RA patients and AS patients, combination therapy and monotherapy, Remicade oriented ADA and Remsima oriented ADA, switch group and maintenance group. All data consistently support the comparability claim and, once published, would provide additional scientific grounds for research similar to Professor Chamaida Plasencia’s.”
In addition, the US Food and Drug Administration (FDA) approved Celltrion’s biosimilar infliximab in April this year for the treatment of serious autoimmune diseases, including RA and IBD. It is now the first and only biosimilar mAb therapy, and only the second biosimilar, to be approved in the US. Pfizer will assume exclusive marketing authority in the US under the brand name InflectraTM and will work closely with Celltrion Healthcare to prepare for the launch.
Mr. Kim said: “We fully support the stringent regulatory pathways in place for biosimilars in Europe and the US. We are proud that our comprehensive data package for Remsima® met these high standards and firmly believe they should be maintained for all future biosimilars – whether for infliximab or another anti-TNF medicine.”
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Notes to Editors:
About biosimilar infliximab
Infliximab is a treatment for many autoimmune diseases, with more than 15 years of clinical data and experience. Celltrion’s biosimilar infliximab is approved in more than 72countries across the globe including the US, Canada, Japan and throughout Europe.
Celltrion’s biosimilar infliximab, under the brand name Remsima®, was licensed by the European Commission in September 2013 for all eight indications of its reference product: moderately to severely active rheumatoid arthritis, active psoriatic arthritis, active ankylosing spondylitis, moderately to severely active adult and pediatric Crohn’s disease, moderately to severely active adult and pediatric ulcerative colitis, and moderately to severely active plaque psoriasis. A second biosimilar infliximab, under the brand name Flixabi®, has recently been licensed for the same indications.
About Celltrion’s extension studies
The PLANETRA and PLANETAS extension studies compared the safety and efficacy of Remsima® to the RMP in patients with rheumatic disease over 102 weeks. After 54 weeks, eligible patients who had completed the main studies were switched from the RMP to biosimilar infliximab and continued with treatment for an additional 48 weeks. The results from these extension studies demonstrated that the efficacy, safety and immunogenicity of Remsima® were comparable to the RMP in both the maintenance and switch groups for the duration of the study period.
About inflammatory bowel diseases
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.[4] They affect an estimated 2.5-3 million people in Europe;[5] CD affects about three people per 1,000 and UC about 5 people per 1,000.4 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.5
About rheumatoid arthritis
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 percent leave work completely within 5 years of diagnosis.[6] 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 the key.
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/
References
[1] Jurado T., et al. (2016). Low levels of infliximab at early stages predict the loss of drug levels and the clinical response at one year of treatment in patients with rheumatoid arthritis. EULAR 2016, Abstract FRI0167.
[2] Yoo D. H., et al. (2016). Efficacy and safety of CT-P13 (infliximab biosimilar) in patients with rheumatoid arthritis: comparison between switching from infliximab to CT-P13 and continuing CT-P13 in the PLANETRA extension study. Ann Rheum Dis Published Online First: 29 April 2016doi:10.1136/annrheumdis-2015-208786.
[3] Park, W., et al. (2016). 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 Published Online First: 26 April 2016 doi:10.1136/annrheumdis-2015-208783.
[4] Molodecky N. A., et al. (2012). Increasing incidence and prevalence of the inflammatory bowel diseases with time, based on systematic review. Gastroenterology, 142(1), 46-54.
[5] Burisch J., et al. (2013). The burden of inflammatory bowel disease in Europe. Journal of Crohn's and Colitis, 7(4), 322-337.
[6] European Fit for Work Report. (n.d.). Retrieved June 28, 2016, from www.nras.org.uk/european-fit-for-work-report.