CT-P43 (ustekinumab)

CT-P43 Approval Pending

CT-P43 (ustekinumab)

CT-P43 Approval Pending

U.S. License Holder:

Celltrion

Date of License:

aBLA submitted to FDA June-2023

Last Update:

Nov-15-2024

approved_indications FDA-Approved Indications

CT-P43 (ustekinumab) is not FDA-approved. An aBLA has been submitted to the FDA.

approved_indications Approved Foreign Follow-On Biologics / Biosimilars

Biosimilars Approved In Canada

SteQeyma® (Celltrion) (July-2024)

Biosimilars Approved In The E.U.

SteQeyma® (Celltrion) (August-2024)

Biosimilars Approved In South Korea

SteQeyma® (Celltrion) (June-2024)

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Methodology

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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