2 April 2019 - - The Lancet has published the full data-set from UK-based Celltrion Healthcare's randomised controlled trial of CT-P13 (biosimilar infliximab) in Crohn's disease, the PLANETCD Study, the company said.

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.

CT-P13 is already approved for the treatment of eight autoimmune diseases including CD, a form of inflammatory bowel disease, 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 and efficacy, as well as comparability in safety and immunogenicity

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.

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.

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.

The study used the Crohn's Disease Activity Index, 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 between the two drugs fell within the pre-specified margin.

Inflammatory bowel diseases, including Crohn's disease and ulcerative colitis, are chronic disabling gastrointestinal disorders that impact every aspect of a patient's life.

They affect an estimated 5m people globally; IBDs account for substantial costs to the healthcare system and society; the direct healthcare costs of IBDs are estimated to be EUR 4.6-5.6bn per year.


CT-P13 is developed and manufactured by Celltrion, Inc. and was the world's first monoclonal antibody biosimilar approved by the European Commission.

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.

Celltrion Healthcare's 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.