CT-P47 Approval Pending
CT-P47 Approval Pending
U.S. License Holder:
Celltrion
Date of License:
aBLA submitted to FDA January-2024
Last Update:
Jan-23-2025
FDA-Approved IndicationsCT-P47 (tocilizumab) is not FDA-approved. An aBLA has been submitted to the FDA.
Approved Foreign Follow-On Biologics / BiosimilarsAvtozma (Celltrion) (December-2024)
Inter Partes Review ProceedingsU.S. Patent No.
8,580,264 (Subcutaneously Administered Anti-IL6 Receptor Antibody)
Patent Owner
Chugai Seiyaku Kabushiki Kaisha; Hoffmann-La Roche Inc.; Genentech, Inc.
Petitioner(s)
Celltrion, Inc.; Celltrion Healthcare Co. Ltd.; Celltrion Healthcare USA, Inc.
§ 102 Challenge
Y: Claims 1-3, 6-12
Claim Types Challenged Under § 102
Method of Treatment
§ 102 Challenge Instituted
Y
§ 103 challenge
Y: Claims 1-12
Claim Types Challenged Under § 103
Method of Treatment
§ 103 Challenge Instituted
Y
Final Written Decision Issued
Y
Federal Circuit Appeal(s)
24-1115 (Consolidated with lead appeal 24-1111)
IPR Status
Final Written Decision (All Challenged Claims Unpatentable); Federal Circuit Appeal Voluntarily Dismissed
U.S. Patent No.
10,874,677 (Subcutaneously Administered Anti-IL6 Receptor Antibody)
Patent Owner
Chugai Seiyaku Kabushiki Kaisha; Hoffmann-La Roche Inc.; Genentech, Inc.
Petitioner(s)
Celltrion, Inc.; Celltrion Healthcare Co. Ltd.; Celltrion Healthcare USA, Inc.
§ 102 Challenge
Y: Claims 1, 5
Claim Types Challenged Under § 102
Other (Drug Delivery Device)
§ 102 Challenge Instituted
Y
§ 103 challenge
Y: Claims 1-8
Claim Types Challenged Under § 103
Other (Drug Delivery Device)
§ 103 Challenge Instituted
Y
Final Written Decision Issued
Y
Federal Circuit Appeal(s)
24-1111 (Lead, consolidated with 24-1115)
IPR Status
Final Written Decision (All Challenged Claims Unpatentable); Federal Circuit Appeal Voluntarily Dismissed
Information contained in the Venable 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 BiologicsHQ database.
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