RT Journal Article
SR Electronic
T1 Biosimilars in rheumatology: what the clinician should know
JF RMD Open
JO RMD Open
FD EULAR
SP e000010
DO 10.1136/rmdopen-2014-000010
VO 1
IS 1
A1 Castañeda-Hernández, Gilberto
A1 González-Ramírez, Rodrigo
A1 Kay, Jonathan
A1 Scheinberg, Morton A
YR 2015
UL http://rmdopen.bmj.com/content/1/1/e000010.abstract
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.