Biosimilars in rheumatology: what the clinician should know.
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.
Departamento de Farmacología , Centro de Investigación y de Estudios Avanzados del Instituto Politécnico Nacional , México, Distrito Federal , Mexico ; Centro Latino Americano de Pesquisa em Biológicos , Rio de Janeiro , Brazil.
Gilberto
G
Castañeda-Hernández
Departamento de Farmacología , Centro de Investigación y de Estudios Avanzados del Instituto Politécnico Nacional , México, Distrito Federal , Mexico.
Rodrigo
R
González-Ramírez
Division of Rheumatology, Department of Medicine , University of Massachusetts Medical School and UMass Memorial Medical Center , Worcester, Massachusetts , USA.
Jonathan
J
Kay
Hospital AACD , São Paulo, São Paulo , Brazil ; Hospital Israelita Albert Einstein , São Paulo, São Paulo , Brazil.
Morton A
MA
Scheinberg
Anti-TNF; Outcomes research; Pharmacokinetics