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:

Dec-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)

Related News

Biosimilar Updates: EYLEA® IPR Filings, Herceptin® Biosimilar Hercessi™ Launch, Stelara® Biosimilar Yesintek™ Approval
Robert S. Schwartz, Ph.D.
December 6, 2024
Accord BioPharma’s Stelara® Biosimilar Imuldosa™ Approved by FDA
Robert S. Schwartz, Ph.D.
October 18, 2024
Fresenius Kabi and Formycon Announce Approval of Stelara® Biosimilar Otulfi™ in the U.S. and E.U.
Robert S. Schwartz, Ph.D.
October 1, 2024
Venable’s BiologicsHQ Monthly Injection – July 2024
Monica Chou Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D.
August 10, 2024
FDA Accepts Bio-Thera’s aBLA for Proposed Stelara® (ustekinumab) Interchangeable BAT2206
Robert S. Schwartz, Ph.D.
July 31, 2024
Venable’s BiologicsHQ Monthly Injection – June 2024
Monica Chou Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D.
July 9, 2024
Alvotech and Teva’s Selarsdi™ (ustekinumab-aekn), Biosimilar to Stelara® Approved by FDA
Monica Chou Robert S. Schwartz, Ph.D.
April 23, 2024
Stelara® Biosimilar Updates: Settlement of IPR and FDA Review of Proposed Biosimilar
Monica Chou Robert S. Schwartz, Ph.D.
March 6, 2024
Stelara® Biosimilar Updates: IPR Petition Challenging U.S. Patent No. 10,961,307 Filed and SB17 Settlement and Launch Date Announced
Monica Chou Robert S. Schwartz, Ph.D.
December 8, 2023
First Biosimilar and Interchangeable of Stelara® (ustekinumab) Approved in the U.S.
Robert S. Schwartz, Ph.D.
November 5, 2023
First List of Drugs for Medicare Price Negotiations Published Includes Three Biologics
Ha Kung Wong
September 25, 2023
Venable’s BiologicsHQ Monthly Injection – August 2023
Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D. Ha Kung Wong
September 12, 2023

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.

Disclaimer

The individuals who maintain this site work for Venable LLP. The information, comments and links posted on this site do not constitute legal advice. No attorney-client relationship has been or will be formed by any communication(s) to, from or with the site and/or the author. For legal advice, contact an attorney at Venable LLP or an attorney actively practicing in your jurisdiction. Do not send any confidential or privileged information to the author; neither Venable LLP nor the author will assume any liability or responsibility for it. If you send any information, documents or materials to the site, you give permission for the author to include them on or in the site. No information, documents or materials you send to the site will be considered confidential or privileged by Venable LLP or its lawyers. Also, no such information, documents or materials will be returned to you. All decisions relating to the content belong to the author.

Subscribe for Future Updates

    captcha