Use of Biologics and Biosimilars in Rheumatology.

Prior to the availability of biologics, synthetic DMARDs (Disease modifying anti-rheumatic drugs) were the mainstay of the treatment in rheumatology. With the introduction of biologics, the scenario is changing to become more promising. These drugs have innovative mechanism of action, based on the targeted inhibition of specific molecular or cellular targets directly involved in disease pathogenesis. The biosimilars are highly similar copies of originator biologics approved through pre-defined, stringent regulatory processes after rigorous physicochemical, non-clinical, and clinical evaluations. Low cost and resulting wider patient access as compared to innovators goes in favor of biosimilars. Regulatory guidelines for biosimilar development and approval are rigorous and undergoing constant refinement. Approval of several biosimilars in across the world in last few years bears testimony to the increased regulatory acceptance of these agents. This article addresses development of biosimilars, regulatory process, benefits and concerns about their usage in rheumatologic practice.