PT - JOURNAL ARTICLE AU - Gilberto Castañeda-Hernández AU - Rodrigo González-Ramírez AU - Jonathan Kay AU - Morton A Scheinberg TI - Biosimilars in rheumatology: what the clinician should know AID - 10.1136/rmdopen-2014-000010 DP - 2015 May 01 TA - RMD Open PG - e000010 VI - 1 IP - 1 4099 - http://rmdopen.bmj.com/content/1/1/e000010.short 4100 - http://rmdopen.bmj.com/content/1/1/e000010.full SO - RMD Open2015 May 01; 1 AB - Biosimilars are now a reality in rheumatology. Although analytical and non-clinical procedures to establish similarity have evolved significantly, clinical trials demonstrating equivalent efficacy and safety are absolutely required for all biosimilars. The design of such trials, including equivalence and non-inferiority statistical approaches, are discussed. Clinical evidence on biosimilars that have been approved recently or are presently being developed for use in rheumatology is also reviewed and contrasted with that available for biomimics (or intended copies), which are non-innovator biologics that are marketed in several countries but have not undergone review according to a regulatory pathway for biosimilars.