EMEA guidelines on biosimilars and their clinical implications.
Rossert
Jerome
J
Amgen Global Safety, Thousand Oaks, Calif. 91320, USA. jrossert@amgen.com
D000818:Animals; D004353:Drug Evaluation, Preclinical / Q000592:standards; D016568:Drugs, Generic / Q000592:standards*; D005060:Europe; D017408:Guidelines as Topic / Q000592:standards*; D006801:Humans; D016032:Randomized Controlled Trials as Topic / Q000592:standards*; D013810:Therapeutic Equivalency
D016568:Drugs, Generic