Simponi® — Venable's BiologicsHQ

U.S. License Holder:

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

Date of License:

April-24-2009

Last Update:

October-08-2026

FDA-Approved Indications

SIMPONI (golimumab) is a tumor necrosis factor (TNF) blocker indicated for the treatment of:

Adult patients with moderately to severely active rheumatoid arthritis (RA) in combination with methotrexate;

Adult patients with active psoriatic arthritis (PsA) alone, or in combination with methotrexate;

Adult patients with active ankylosing spondylitis (AS);

Adult and pediatric patients weighing at least 15 kg with moderate to severely active ulcerative colitis (UC).

aBLA / 505(b)(2) Activity

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

Immgolis: Accord / Bio-Thera (May-2026, Interchangeable)

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

AVT05: Alvotech / Teva (January-2025; CRL November-2025, Resubmitted June-2026)

Approved Foreign Follow-On Biologics / Biosimilars

Biosimilars Approved In Canada

Upgolyv (JAMP Pharma) (April-2026)

Biosimilars Approved In The E.U.

Gobviaz® (Alvotech / Advanz) (UK, EU: November-2025)
Gotenfia (STADA / Bio-Thera) (February-2026)

Biosimilars Approved In Japan

AVT05 (Alvotech / Fuji Pharma) (September-2025)

Inter Partes Review Proceedings

PTAB Portal

IPR Case No(s):

IPR2026-00256

U.S. Patent No.
11,014,982 (Anti-TNF Antibodies, Compositions, and Methods for the Treatment of Active Ankylosing Spondylitis)

Patent Owner
Janssen Biotech, Inc.

Petitioner(s)
Accord BioPharma, Inc.; Bio-Thera Solutions, Ltd.; Intas Biopharmaceuticals Ltd.

§ 102 Challenge
Y: Claims 1-10

Claim Types Challenged Under § 102
Method of Treatment

§ 102 Challenge Instituted
Y

§ 103 challenge
Y: Claims 1-10

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Y

IPR Status
Instituted, Pending

IPR2026-00257

U.S. Patent No.
11,041,020 (Methods for the Treatment of Active Psoriatic Arthritis)

Patent Owner
Janssen Biotech, Inc.

Petitioner(s)
Accord BioPharma, Inc.; Bio-Thera Solutions, Ltd.; Intas Biopharmaceuticals Ltd.

§ 102 Challenge
Y: Claims 1-10

Claim Types Challenged Under § 102
Method of Treatment

§ 102 Challenge Instituted
Y

§ 103 challenge
Y: Claims 1-10

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Y

IPR Status
Instituted, Pending

IPR2026-00258

U.S. Patent No.
12,122,824 (Anti-TNF Antibodies, Compositions, and Methods for the Treatment of Active Ankylosing Spondylitis)

Patent Owner
Janssen Biotech, Inc.

Petitioner(s)
Accord BioPharma, Inc.; Bio-Thera Solutions, Ltd.; Intas Biopharmaceuticals Ltd.

§ 102 Challenge
Y: Claims 1-7

Claim Types Challenged Under § 102
Method of Treatment

§ 102 Challenge Instituted
Y

§ 103 challenge
Y: Claims 1-7

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Y

IPR Status
Instituted, Pending

IPR2026-00259

U.S. Patent No.
12,291,566 (Anti-TNF Antibodies, Compositions, and Methods for the Treatment of Active Ankylosing Spondylitis)

Patent Owner
Janssen Biotech, Inc.

Petitioner(s)
Accord BioPharma, Inc.; Bio-Thera Solutions, Ltd.; Intas Biopharmaceuticals Ltd.

§ 102 Challenge
Y: Claims 1-7

Claim Types Challenged Under § 102
Method of Treatment

§ 102 Challenge Instituted
Y

§ 103 challenge
Y: Claims 1-7

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Y

IPR Status
Instituted, Pending

U.S. Patent Litigations

PACER

Case No(s):

U.S. Patent Nos.
8,017,325 (Selection of High-Producing Cell Lines) 8,586,356 (Gal alpha1-3gal-containing N-glycans in Glycoprotein Products Derived from CHO Cells) 8,852,889 (Cell Culture Process) 8,956,830 (Methods of Cell Culture) 9,170,249 (N-acetylhexosamine-containing N-glycans in Glycoprotein Products) 9,217,168 (Methods of Cell Culture) 9,475,858 (Cell Culture Process) 9,487,810 (Methods of Cell Culture) 9,663,810 (Methods of Cell Culture) 9,890,410 (N-acetylhexosamine-containing N-glycans in Glycoprotein Products) 11,014,982 (Anti-TNF Antibodies, Compositions, and Methods for the Treatment of Active Ankylosing Spondylitis) 11,041,020 (Methods for the Treatment of Active Psoriatic Arthritis) 12,122,824 (Anti-TNF Antibodies, Compositions, and Methods for the Treatment of Active Ankylosing Spondylitis) 12,129,292 (Anti-Tumor Necrosis Factor (TNF) Antibodies and Compositions Thereof) 12,139,735 (Cell Culture Process) 12,180,271 (Manufacturing Methods for Producing Anti-TNF Antibody Compositions) 12,291,566 (Anti-TNF Antibodies, Compositions, and Methods for the Treatment of Active Ankylosing Spondylitis)

Plaintiffs
Janssen Biotech, Inc.; Janssen Sciences Ireland Unlimited Co.

Defendants
Accord BioPharma, Inc.; Bio-Thera Solutions, Ltd.

Federal Circuit Appeal(s)
27-1008 (Preliminary Injunction)

Status
Case Ongoing, Motion for Preliminary Injunction Granted, Fed. Cir. Appeal of Preliminary Injunction Pending

BPCIA
Y

1:26-cv-01754 (E.D. Va.)

U.S. Patent Nos.
8,017,325 (Selection of High-Producing Cell Lines) 8,852,889 (Cell Culture Process) 8,956,830 (Methods of Cell Culture) 9,170,249 (N-acetylhexosamine-containing N-glycans in Glycoprotein Products) 9,217,168 (Methods of Cell Culture) 9,475,858 (Cell Culture Process) 9,487,810 (Methods of Cell Culture) 9,663,810 (Methods of Cell Culture) 9,890,410 (N-acetylhexosamine-containing N-glycans in Glycoprotein Products) 10,421,986 (Method for the Clarification of High-Density Crude Cell Culture Harves) 11,225,516 (Transition Analysis Method for Chromatography Column Qulaification) 12,139,735 (Cell Culture Process) 12,534,524 (Manufacturing Methods for Producing Anti-TNF Antibody Compositions) 12,595,454 (Methods of Continuous Cell Culture)

Plaintiffs
Janssen Biotech, Inc.; Janssen Sciences Ireland UC

Defendants
Alvotech hf; Alvotech USA Inc.; Teva Pharmaceuticals USA, Inc.

Status
Case Ongoing, Motion for Preliminary Injunction Pending

BPCIA
Y

4:09-cv-11362 (D. Mass.)

U.S. Patent Nos.
5,654,407 (Human Anti-TNF Antibodies)

Plaintiffs
Bayer Healthcare, LLC

Defendants
Centocor Ortho Biotech, Inc.

Federal Circuit Appeal(s)
11-1207

Status
Case Terminated

BPCIA
N

4:09-cv-40089 (D. Mass.)

U.S. Patent Nos.
7,223,394 (Human Antibodies that Bind Human TNF-Alpha) 7,541,031 (Methods for Treating Rheumatoid Arthritis using Human Antibodies that Bind Human TNF-Alpha)

Plaintiffs
AbbVie Biotechnology Ltd.; AbbVie Inc.; Abbott Laboratories

Defendants
Centocor Ortho Biotech, Inc.

Status
Dismissed

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.

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Simponi® (golimumab)

Simponi® (golimumab)

FDA-Approved Indications

aBLA / 505(b)(2) Activity

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

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

Approved Foreign Follow-On Biologics / Biosimilars

Biosimilars Approved In Canada

Biosimilars Approved In The E.U.

Biosimilars Approved In Japan

Inter Partes Review Proceedings

IPR Case No(s):

IPR2026-00256

IPR2026-00257

IPR2026-00258

IPR2026-00259

U.S. Patent Litigations

Case No(s):

1:26-cv-00222 (D. Del.)

1:26-cv-01754 (E.D. Va.)

4:09-cv-11362 (D. Mass.)

4:09-cv-40089 (D. Mass.)

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