CHS-1420 (adalimumab)

CHS-1420 Approval Pending

CHS-1420 (adalimumab)

CHS-1420 Approval Pending

U.S. License Holder:

Coherus BioSciences, Inc.

Date of License:

aBLA accepted by FDA February-2021

Last Update:


approved_indications FDA-Approved Indications

CHS-1420 (adalimumab) is not FDA-approved. An aBLA has been accepted by the FDA.

approved_indications Inter Partes Review Proceedings

PTAB Portal

IPR Case No(s):

U.S. Patent No.
10,155,039 (Stable Aqueous Formulations of Adalimumab)

Patent Owner
Coherus BioSciences, Inc.

Fresenius Kabi USA, LLC; Fresenius Kabi Swissbiosim GmbH

§ 102 Challenge

§ 103 challenge

IPR Status
Challenges Include Written Description, Enablement, and Indefiniteness; Institution Denied; Request for Rehearing of Institution Decision Denied


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 ( 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 ( 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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