CelltrionHealthcare

Experts caution that data only apply to biosimilars studied

14^th November 2016, Washington, United States.  New data presented today at the 2016 American College of Rheumatology (ACR) Annual Meeting demonstrate that the efficacy and safety profile of CT-P10 (biosimilar rituximab) in rheumatoid arthritis (RA) patients is comparable to patients treated with originator rituximab over 24 weeks.[1]^,[2]

A total of 372 RA patients (161 patients on CT-P10 and 211 patients on originator rituximab) were enrolled in a trial looking at efficacy and pharmacokinetic (PK) equivalence as well as comparing pharmacodynamics (PD) and safety. Results from the Phase III, randomised, controlled study showed that overall efficacy, PD and safety profiles were highly similar between CT-P10 and the originator rituximabs (U.S. sourced originator  rituximab and EU sourced originator  rituximab).[1]

Additional data presented at the congress found equivalent PK and similar safety profiles among CT-P10 and the two originator rituximabs sourced from different manufacturers could also be demonstrated.[2]

Man Hoon Kim, President and CEO of Celltrion Healthcare, said: “We have conducted studies that consistently demonstrate the equivalence and comparability of our biosimilar infliximab CT-P13 to the originator infliximab and are proud to be able to present similar data for our second biosimilar CT-P10.

“Our mission at Celltrion Healthcare is to develop quality biosimilar treatments. We are committed to gathering robust clinical data on CT-P10, in the hope that it too can significantly improve access to modern therapies for millions of patients suffering from chronic diseases.”

Real-world data in support of CT-P13

Celltrion Healthcare has already seen success with CT-P13 - the world’s first monoclonal antibody biosimilar approved by the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA).[3] Data presented at the ACR Annual Meeting, from the long-anticipated NOR-SWITCH study revealed that the efficacy and safety were maintained in patients switched to CT-P13 from originator infliximab and is not inferior to those who continued treatment with the originator. The results indicate that patients can be safely switched.[4] These findings were previously presented at the 2016 United European Gastroenterology (UEG) Week in October.

Tore Kvien, Professor at the Department of Rheumatology, Diakonhjemmet Hospital in Oslo, Norway, and lead author of the NOR-SWITCH study, said: “Results were consistent for both primary and secondary efficacy endpoints and showed that switching to CT-P13 was not inferior to continued treatment with the originator infliximab. Additionally, the safety profile, anti-drug antibody formation and drug trough levels were similar. This means physicians can have confidence that CT-P13 is genuinely comparable to the originator biologic. It is, however, important to remember that these data apply specifically to CT-P13 and cannot be transferred to other biosimilars.

 “Switching of this nature can provide significant cost savings to healthcare systems and improve patient access to life-changing treatment for chronic conditions such as rheumatoid arthritis.”

--- Ends---

Notes to editors:

Additional quotes from physicians about CT-P13 and CT-P10

Jørgen Jahnsen, Professor of Gastroenterology at the University of Oslo, Norway, and co-author of the NOR-SWITCH study, said: “NOR-SWITCH was designed to assess the efficacy, safety and immunogenicity of switching patients from originator to biosimilar CT-P13. The results are positive and show that safety and efficacy are maintained post-switch and should give confidence to physicians looking to move their patients onto CT-P13 for non-medical reasons such as cost. It is important to note these results do not apply to other biosimilars, even biosimilar infliximabs.”

Professor John Isaacs, Director of the Institute of Cellular Medicine at Newcastle University and consultant rheumatologist at the Freeman Hospital, said: “Patient safety is critical. These data add to the bank of evidence in the rheumatology field and should help patients access disease modifying biologic therapies. But it is important to recognise that these data for CT-P10 cannot be extrapolated to biosimilars generally.”

About CT-P10 (biosimilar rituximab)

Rituximab is a CD20-directed cytolytic antibody indicated for the treatment of patients with non-Hodgkin’s lymphoma (NHL), chronic lymphocytic leukemia (CLL), rheumatoid arthritis (RA), granulomatosis with polyangiitis, and microscopic polyangiitis.

CT-P10 is a rituximab biosimilar candidate. The primary results of the first clinical study of CT-P10 – a phase I RCT versus innovator rituximab in patients with active RA – were recently published and demonstrated the pharmacokinetics (PK) of the two drugs after a single course of treatment were statistically equivalent, and that their efficacy, pharmacodynamics (PD), immunogenicity, and safety were similar up to week 24. The clinical data of phase I 72-week extension study and an additional 1 year switching study were presented in ACR 2015 and EULAR 2016. Three phase III RCT studies in patients with RA, advanced follicular lymphoma (AFL) and low-tumor-burden follicular lymphoma (LTBFL) are ongoing. Equivalent pharmacokinetics and efficacy were demonstrated between CT-P10 and innovator rituximab and presented in ACR 2016.

CT-P10 studies presented at ACR 2016

• 1634 CH. Suh, et al. Pharmacokinetics and Safety of Three Formulations of Rituximab (CT-P10, US-sourced Innovator Rituximab and EU-sourced Innovator Rituximab) in Patients with Rheumatoid Arthritis: Results from Phase 3 Randomized Controlled Trial over 24 Weeks

   

• 1635 DH. Yoo, et al. Efficacy and Safety of CT-P10, Rituximab Biosimilar Candidate, and Innovator Rituximab in Patients with Rheumatoid Arthritis: Results from Phase 3 Randomized Controlled Trial over 24 Weeks

   

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 75 (as of September 20, 2016) countries including the US, Canada, Japan and throughout Europe.

About the NOR-SWITCH study

The Norwegian government wanted to determine the impact of switching adult patients who were stable on originator infliximab to the biosimilar (CT-P13), and funded NOR-SWITCH to evaluate this across all inflammatory diseases for which infliximab is approved.

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 patient organisations.[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 per cent 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 key.

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/

References