The future landscape of biosimilars in rheumatology: Where we are where we are going.

Abstract

The upcoming of biosimilars in rheumatic diseases have generated considerable interest throughout the past five years among pharmaceutical industries and regulatory agencies, their development is associated with considerable variation and heterogeneity on the variable requirements for license and marketing throughout the various continents. In this article we reviewed the contents of the conference presented on the last XI International Conference in Autoimmunity in Lisbon. Truly biosimilars that followed requirements from stringent agencies are now available and licensed for infliximab, etanercept, adalimumab and rituximab but several compounds from the same mechanism of action are also being developed and are reviewed and the strengths of their evidence analized and discussed. The use of intended copies (biomimics) and its presence in less regulated markets are also reviewed and the risks of their use without proper monitoring is also evaluated. Biosimilars for rheumatic diseases is expected to change the access of patients to high costs biologics and gradually more and more patients are being switched to biosimilars either by the rheumatologist prescription or mandatory national indications. The economic impact is expected to be huge in the coming years. Second generation biosimilars are also being developed and clinical trials are underway for license in the near future.