Biosimilar DMARDs: What Does the Future Hold?

Abstract

Biological medicinal products, albeit fundamental in unresponsive inflammatory rheumatic diseases, represent a significant economic burden to healthcare systems worldwide. A new landmark in the treatment of these conditions was achieved with the European Medicines Agency’s endorsement of CT-P13, the first biosimilar of a monoclonal antibody, infliximab. The main driving force behind biosimilar development is to improve accessibility at lower costs, provided the quality, efficacy and safety of the biosimilar is similar to that of the reference drug. Many other biosimilar candidates are currently under development and will probably be approved in the near future, posing complex prescribing decisions for rheumatologists. In this article, biosimilar disease-modifying anti-rheumatic drugs (DMARDs) are put into perspective: what they are, the stepwise manufacturing process and the available mechanisms that regulate the thorough comparability exercise. Non-clinical and clinical data leading to CT-P13 approval are briefly reviewed, and current clinical data on upcoming biosimilars are also addressed. Other matters covered include extrapolation of clinical indications, interchangeability and automatic substitution. As cumulative evidence on the use of biosimilars grows, controversies abate and patients and physicians become reassured. However, adequate answers to the uncertainties still surrounding biosimilar agents are necessary to ensure the trust of rheumatologists and, on a larger scale, to guarantee their widespread use and success.