Otulfi (ustekinumab-aauz)

aBL 761379

Otulfi (ustekinumab-aauz)

aBL 761379

U.S. License Holder:

Fresenius Kabi / Formycon

Date of License:

September-27-2024

Last Update:

Dec-15-2024

approved_indications FDA-Approved Indications

OTULFI (ustekinumab-aauz) is a human interleukin -12 and -23 antagonist indicated for the treatment of:

Adult patients with:

Moderate to severe plaque psoriasis (PsO) who are candidates for phototherapy or systemic therapy;

Active psoriatic arthritis (PsA);

Moderately to severely active Crohn's disease (CD);

Moderately to severely active ulcerative colitis.

Pediatric patients 6 years and older with:

Moderate to severe plaque psoriasis, who are candidates for phototherapy or systemic therapy;

Active psoriatic arthritis (PsA).

approved_indications Approved Foreign Follow-On Biologics / Biosimilars

Biosimilars Approved In The E.U.

Fymskina (Formycon) (September-2024)
Otulfi (Fresenius Kabi) (Septenber-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.

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