Biosimilars.

Abstract

Biological therapies have widened the therapeutic armamentarium for immune-mediated inflammatory diseases, providing in many cases a broad range of treatment options with different mechanisms of action. The widespread use of biological agents in systemic lupus erythematosus is currently limited to belimumab and rituximab, although results of promising larger Phase III clinical trials are awaited or have been recently circulated, especially for anti-cytokine therapies. The loss of exclusivity over the last years for several originator biologics has started the successful introduction of biosimilar products into clinical practice. There is an abbreviated pathway to biosimilar approval, but this is underpinned by the same standards of pharmaceutical quality, safety and efficacy that apply to all biological medicines. Nevertheless, there are unique reasons why development of biosimilars may be particularly challenging in lupus.