Celltrion Healthcare: Lancet Publishes Full Data-Set from Influential NOR-SWITCH Study

Detailed results from NOR-SWITCH, a randomized, double-blind, switching study of biosimilar infliximab, CT-P13 (Remsima^®/ Inflectra™) were published in the prestigious journal The Lancet.

Sponsored by the Norwegian government, the study explored the impact of switching adult patients who were stable on reference infliximab to Celltrion Healthcare’s biosimilar CT-P13. The results demonstrate that CT-P13 is not inferior to continued treatment with the reference product and that patients can be safely switched. ¹

Dr Kwon, Medical Director at Celltrion Healthcare said: “The publication of the NOR-SWITCH data in The Lancet marks another important milestone on the path to increasing physician confidence in using biosimilar infliximab when looking to switch their patients.”

Following presentations at both the 2016 United European Gastroenterology (UEG) Week and the American College of Rheumatology (ACR) Annual Meeting, the findings from the study revealed that out of the 50% of patients switched to CT-P13, the proportion of patients with disease worsening were comparable to those who remained on reference infliximab (29.6 and 26.2% respectively.) The data discontinuation rates due to a lack of efficacy for reference infliximab and biosimilar infliximab were eight and three respectively. The time to study drug discontinuation was almost identical between the two groups, with similar overall remission rates and frequencies of adverse events also observed. ¹

Tore K. Kvien, Head of Department of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway, and the lead author of the NOR-SWITCH study, also said: “NOR-SWITCH results show that efficacy and safety were comparable between patients switched to CT-P13 and those who continued treatment with reference infliximab, proving that patients can be safely switched to CT-P13. As the data are specific to CT-P13, we must be clear that these findings can only apply to this particular biosimilar.”

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Notes to editors:

About the NOR-SWITCH study

The Norwegian government wanted to determine the impact of switching adult patients who were stable on reference infliximab to biosimilar (CT-P13), and funded NOR-SWITCH to evaluate this across all inflammatory diseases for which infliximab is approved (Crohn’s disease, ulcerative colitis, rheumatoid arthritis, spondyloarthritis, psoriatic arthritis or chronic plaque psoriasis).

Involving nearly 500 patients, the study was designed by a multidisciplinary and multiregional project group with special competence in performance of strategy trials, immunogenicity, and statistics led by Professor Tore Kvien at the Department of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway. Additionally, the group consisted of representatives from the three relevant patient organisations.²

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 Medicines Agency (EMA). It is indicated for the treatment of eight autoimmune diseases including rheumatoid arthritis and inflammatory bowel disease. It was approved by the EMA under the trade name Remsima^® in September 2013 and launched in Europe in early 2015. The US FDA approved Celltrion’s CT-P13 in April 2016 under the trade name Inflectra™. Celltrion’s CT-P13 is approved in more than 79 (as of January 2017) countries including the US, Canada, Japan and throughout Europe.

About Celltrion Healthcare

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

About The Lancet medical journal

The Lancet is one of the world's leading independent general medical journal. The peer-reviewed journal publishes medical news, original research, and reviews on all aspects of clinical medicine and International Health. The Lancet has an Impact Factor of 44.002.

References

¹ Jørgensen, K. et al. Switching from originator infliximab to biosimilar CT-P13 compared with maintained treatment with originator infliximab (NOR-SWITCH): a 52-week, randomised, double-blind, non-inferiority trial. The Lancet, Available at: http://dx.doi.org/10.1016/S0140-6736(17)30068-5 [accessed May 2017].

² GAFPA. NOR-SWITCH. Available at: http://1yh21u3cjptv3xjder1dco9mx5s.wpengine.netdna-cdn.com/wp-content/uploads/2016/09/GAfPA_Norswitch_Sept.-2016.pdf [accessed May 2017].

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