U.S. License Holder:
Date of License:
aBLA accepted by FDA September-2018
SB5 (adalimumab) is not FDA-approved. An aBLA has been submitted to the FDA.
Approved Foreign Follow-On Biologics / Biosimilars
Biosimilars Approved In Canada
Hadlima (Samsung Bioepis) (May-2018)
Biosimilars Approved In The E.U.
Imraldi (Samsung Bioepis) (August-2017)
Biosimilars Approved In Australia
Hadlima (Samsung Bioepis) (January-2018)
Biosimilars Approved In South Korea
SB5 (Samsung Bioepis) (September-2017)