Stelara® — Venable's BiologicsHQ

U.S. License Holder:

Centocor Ortho Biotech Inc. (Janssen Biotech, Inc.)

Date of License:

September-25-2009 [September-23-2016]

Last Update:

June-23-2025

FDA-Approved Indications

STELARA (ustekinumab) 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).

aBLA / 505(b)(2) Activity

aBLA / 505(b)(2) Approved by FDA

Wezlana: Amgen (October-2023 Interchangeable) Selarsdi: Alvotech / Teva (April-2024, May-2025 Interchangeable) Pyzchiva®: Samsung Bioepis / Sandoz (June-2024 Provisionally Interchangeable) Otulfi®: Fresenius Kabi / Formycon (September-2024, May-2025 Interchangeable) Imuldosa®: Accord BioPharma (October-2024) Yesintek: Biocon (November-2024) Steqeyma: Celltrion (December-2024) Starjemza: Bio-Thera Solutions / Hikma (May-2025, Interchangeable+I340)

Approved Foreign Follow-On Biologics / Biosimilars

Biosimilars Approved In Canada

Jamteki (Alvotech / JAMP Pharma) (November-2023)
Otulfi® (Fresenius Kabi) (December-2024)
Steqeyma (Celltrion) (July-2024)
Wezlana (Amgen) (December-2023)

Biosimilars Approved In The E.U.

Eksunbi (Samsung Bioepis) (September-2024)
Fymskina (Formycon) (September-2024)
Imuldosa / Absimky (Accord) (December-2024)
Otulfi® (Fresenius Kabi) (September-2024)
Pyzchiva® (Sandoz / Samsung Bioepis) (April-2024)
Qoyvolma (Celltrion) (June-2025)
SteQeyma® (Celltrion) (August-2024)
Uzpruvo® (Alvotech / STADA Arzneimittel) (January-2024)
Wezenla (Amgen) (June-2024)
Yesintek (Biocon) (February-2025 EU, May-2025 UK)

Biosimilars Approved In Australia

Wezlana® (Amgen) (January-2024)

Biosimilars Approved In Japan

AVT04 (Alvotech / Fuji Pharma) (September-2023)
Ustekinumab BS (Biocon) (January-2025)

Biosimilars Approved In South Korea

Epyztek (Samsung Bioepis) (April-2024)
Steqeyma (Celltrion) (June-2024)

Inter Partes Review Proceedings

PTAB Portal

IPR Case No(s):

IPR2023-01103

U.S. Patent No.
10,961,307 (Methods of Treating Moderately to Severely Active Ulcerative Colitis by Administering an Anti-IL12/IL23 Antibody)

Patent Owner
Janssen Biotech, Inc.

Petitioner(s)
Samsung Bioepis Co., Ltd.

§ 102 Challenge
Y: Claims 1-4, 6-22, 24-34

Claim Types Challenged Under § 102
Method of Treatment

§ 102 Challenge Instituted
Terminated Prior to Institution Decision

§ 103 challenge
Y: Claims 1-34

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Terminated Prior to Institution Decision

Settled / Challenged Claims Disclaimed / Challenge Terminated
Y (Settled Prior to Institution Decision)

IPR Status
Settled Prior to Institution Decision

IPR2023-01444

U.S. Patent No.
10,961,307 (Methods of Treating Moderately to Severely Active Ulcerative Colitis by Administering an Anti-IL12/IL23 Antibody)

Patent Owner
Janssen Biotech, Inc.

Petitioner(s)
Biocon Biologics Inc.; Biocon Biologics Limited; Biocon Biologics UK Limited; Biocon Limited

§ 102 Challenge
Y: Claims 1-4, 6-22, 24-34

Claim Types Challenged Under § 102
Method of Treatment

§ 102 Challenge Instituted
Terminated Prior to Institution Decision

§ 103 challenge
Y: Claims 1-34

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Terminated Prior to Institution Decision

Settled / Challenged Claims Disclaimed / Challenge Terminated
Y (Settled Prior to Institution Decision)

IPR Status
Settled Prior to Institution Decision

U.S. Patent Litigations

PACER

Case No(s):

1:22-cv-01549 (D. Del.)

U.S. Patent Nos.
6,902,734 (Anti-IL-12 Antibodies and Compositions Thereof) 8,852,889 (Cell Culture Process) 9,217,168 (Methods of Cell Culture) 9,475,858 (Cell Culture Process) 9,663,810 (Methods of Cell Culture) 10,961,307 (Methods of Treating Moderately to Severely Active Ulcerative Colitis by Administering an Anti-IL12/IL23 Antibody)

Plaintiffs
Janssen Biotech, Inc.

Defendants
Amgen, Inc.

Status
Stipulated Dismissal Due to Settlement

BPCIA
Y

4:09-cv-11340 (D. Mass.)

U.S. Patent Nos.
6,914,128 (Human Antibodies that Bind Human IL-12 and Methods for Producing) 7,504,485 (Human Antibodies that Bind Human IL-12)

Plaintiffs
Abbott Bioresearch Center, Inc.; Abbott Biotechnology Ltd; Abbott GmbH and Co. KG; AbbVie Deutschland GmbH and Co. KG; AbbVie Bioresearch Center, Inc.

Defendants
Centocor Biologics LLC; Centocor Ortho Biotech, Inc. Janssen Biotech, Inc.

Federal Circuit Appeal(s)
13-1338 13-1346

Status
Jury Verdict (Claims Invalid); Federal Circuit Affirmed

BPCIA
N

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.

Stelara® (ustekinumab)