About Mark Fletcher and Martin Knight

Mark Fletcher, Executive Medical Director, inflammation, infectious disease and general medicine (iiGM) Martin Knight, Senior Director of Strategy and Planning, inflammation, infectious disease and general medicine (iiGM)

Is a different recruitment strategy required to enroll RA biosimilar studies? How to succeed despite increasing volume of RA biosimilar development programs.

Introduction

RA Biosimilar Recruitment

Although a range of regulatory definitions exist, a biosimilar drug is generally defined as a biological compound that is highly similar to the reference drug, with no clinically meaningful differences in safety, purity and potency.1,2 In addition, biosimilars can be characterized as reducing healthcare costs while maintaining clinical efficacy and safety outcomes similar to the originator biologic.1

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New Mechanisms of Action for Disease Modification in RA

Rheumatoid arthritis (RA) is an autoimmune disease primarily affecting the musculoskeletal system with typical symptoms including swollen and painful joints, joint stiffness and loss of function, ultimately leading to disability if untreated. RA also produces significant systemic affects such as fatigue and depression that may appreciably impact quality of life for many patients. Prevalence varies between 0.3 – 1.0% and is more common in women and in developed countries.1

Rheumatoid arthritis
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