U.S. License Holder:
Celltrion
Date of License:
aBLA submitted to FDA November-2020
Last Update:
January-23-2023
FDA-Approved Indications
Yuflyma (adalimumab) is not FDA-approved. An aBLA has been sutmitted to the FDA.
Approved Foreign Follow-On Biologics / Biosimilars
Biosimilars Approved In Canada
Yuflyma (high-concentration) (Celltrion) (December-2021)
Biosimilars Approved In The E.U.
Yuflyma (high-concentration) (Celltrion) (February-2022)Yuflyma (low-concentration) (Celltrion) (February-2021)
Biosimilars Approved In South Korea
Yuflyma (high-concentration) (Celltrion) (October-2021)