Yuflyma (adalimumab)

Yuflyma Approval Pending

Yuflyma (adalimumab)

Yuflyma Approval Pending

U.S. License Holder:

Celltrion

Date of License:

aBLA submitted to FDA November-2020

Last Update:

September-30-2022

approved_indications FDA-Approved Indications

Yuflyma (adalimumab) is not FDA-approved. An aBLA has been sutmitted to the FDA.

approved_indications 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)

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Methodology

Information contained in the Venable Fitzpatrick BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website (www.fda.gov). Information relating to FDA licensed products, FDA-approved indications, and aBLA and 505(b)(2) applications is obtained from public sources including the U.S. FDA website (www.fda.gov). Information relating to litigations is given only for cases active from January 31, 2010 onward. Information relating to foreign biosimilar / biologics follow-on products approved in Australia, Canada, the E.U., Japan and South Korea is from public sources. Statistics graphics are compiled from information contained in the Venable Fitzpatrick BiologicsHQ database.

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