Simponi Aria® (golimumab)

BL 125433

Simponi Aria® (golimumab)

BL 125433

U.S. License Holder:

Janssen Biotech

Date of License:

July-18-2013

Last Update:

September-08-2026

approved_indications FDA-Approved Indications

SIMPONI ARIA (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;

Active Psoriatic Arthritis (PsA) in patients 2 years of age and older;

Adult patients with active Ankylosing Spondylitis (AS);

Active polyarticular Juvenile Idiopathic Arthritis (pJIA) in patients 2 years of age and older.

approved_indications aBLA / 505(b)(2) Activity

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

Immgolis Intri: 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_indications 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

approved_indications U.S. Patent Litigations

PACER

Case No(s):

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

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.

Status
Case Ongoing, Motion for 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

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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