A pharmacokinetic evaluation of the rituximab biosimilar CT-P10 in the treatment of rheumatoid arthritis

ABSTRACT

Introduction

CT-P10 is the first biosimilar of rituximab (RTX) for the treatment of rheumatoid arthritis (RA). The application of valuable biosimilar for the treatment of RA may decrease economic burden of society, and disease activity of RA. Thus, it is worthwhile to identify the economic advantage and further requirement for the proper use of CT-P10 in real world.

Areas covered

Literature searching was performed to identify suitable references written in English for this review article. Rituximab, biosimilar, CT-P10, and rheumatoid arthritis were used as keywords. Current state of RA treatment, position of RTX in the recommendations for the treatment of RA, current status of RTX biosimilar development were assessed before evaluating CT-P10 itself. Physicochemical property, pharmacokinetic profile through phase I to phase III studies, pharmacodynamics, toxicology data, clinical efficacy, and safety were reviewed

Expert opinion

As the first biosimilar to originator RTX, CT-P10 may be a useful alternative for the treatment of RA in all indications for originator RTX. In addition, more studies are required to identify long-term effectiveness and safety of CT-P10 in real world. It is also important to find out new indications of CT-P10 and effective mechanisms to lessen nocebo effect against biosimilar including CT-P10.

KEYWORDS:

• CT-P10
• rituximab
• biosimilar
• rheumatoid arthritis
• pharmacokinetics

Article highlights

• CT-P10 is the first biosimilar Rituximab approved for the treatment of RA from both EMA and US FDA

• CT-P10 would be a valid option for the treatment of adult patients with RA who showed an inadequate response or intolerance to DMARDs including anti-TNF agents, and also who had previous episode of hematologic malignant disease or demyelinating diseases.

• It is worthwhile to provide evidences whether CT-P10 shows similar efficacy profile compared with originator RTX in the treatment of RA from real world data.

• Single switching from originator RTX to CT-P10 revealed that there was no meaningful difference in the efficacy and adverse event profiles. But, real world switching study must observe switched patients for long period of time and make sure that switching to CT-P10 in RA patients is safe and effective.

• To lessen nocebo effects, real world study has to be designed to prepare various mechanisms for sharing information about efficacy and safety of switching between patients and healthcare providers

• CT-P10 needs to expand additional indication in the inflammatory rheumatic diseases.

Declaration of interest

D H Yoo is a scientific consultant for Celltrion and on the speaker’s bureau of Celltrion and Celltrion Healthcare. S H Kim is and employee of Celltrion. S J Lee is an employee of Celltrion and holds stock options. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.