Targeted biological therapies have revolutionised the treatment of inflammatory diseases in rheumatology and new agents continue to be developed. The growing demand, coupled with limited competition, is a challenge for healthcare budgets and limits patients’ access to these therapies. Biosimilars, which are biologicals with comparable safety, quality, and efficacy to a reference product, have the potential to address these challenges. Despite biosimilars having been available since 2006, initially in other indications than rheumatoid arthritis (RA), confidence in their use is still an issue for rheumatologists. This symposium discussed the rigorous scientific and regulatory processes by which biosimilarity is determined, the rationale for extrapolation to different indications, and the evidence needed to support incorporating biosimilars into clinical practice in rheumatology.
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