CT-P39 (omalizumab)

CT-P39 Approval Pending

CT-P39 (omalizumab)

CT-P39 Approval Pending

U.S. License Holder:

Celltrion

Date of License:

aBLA for interchangeable biosimilar submitted to FDA March-2024

Last Update:

Dec-15-2024

approved_indications FDA-Approved Indications

CT-P39 (omalizumab) is not FDA-approved. An aBLA has been submitted to the FDA.

approved_indications Approved Foreign Follow-On Biologics / Biosimilars

Biosimilars Approved In Canada

Omlyclo® (Celltrion) (December-2024)

Biosimilars Approved In The E.U.

Omlyclo® (Celltrion) (May-2024 E.U.; July-2024 U.K.)

Biosimilars Approved In South Korea

Omlyclo® (Celltrion) (June-2024)

Related News

Venable’s BiologicsHQ Monthly Injection – July 2024
Monica Chou Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D.
August 10, 2024
Venable’s BiologicsHQ Monthly Injection – May 2024
Damineh Morsali, Ph.D. Monica Chou Robert S. Schwartz, Ph.D.
June 11, 2024
The First Biosimilar Disputes at the Unified Patent Court (UPC)
Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D.
May 22, 2024
Venable’s BiologicsHQ Monthly Injection – March 2024
Monica Chou Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D.
April 10, 2024
Celltrion Submits aBLA for CT-P39, Proposed Interchangeable Biosimilar of Xolair® (omalizumab)
Monica Chou Robert S. Schwartz, Ph.D.
March 31, 2024

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