BAT2506 (golimumab)

BAT2506 Approval Pending

BAT2506 (golimumab)

BAT2506 Approval Pending

U.S. License Holder:

Bio-Thera Solutions / Accord

Date of License:

aBLA accepted by FDA July-2025

Last Update:

Apr-23-2026

approved_indications FDA-Approved Indications

BAT2506 (golimumab) is not FDA-approved. An aBLA has been accepted by the FDA.

approved_indications Approved Foreign Follow-On Biologics / Biosimilars

Biosimilars Approved In The E.U.

Gotenfia (STADA / Bio-Thera) (February-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
Awaiting Institution Decision

§ 103 challenge
Y: Claims 1-10

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Awaiting Institution Decision

IPR Status
Awaiting Institution Decision

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
Awaiting Institution Decision

§ 103 challenge
Y: Claims 1-10

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Awaiting Institution Decision

IPR Status
Awaiting Institution Decision

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
Awaiting Institution Decision

§ 103 challenge
Y: Claims 1-7

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Awaiting Institution Decision

IPR Status
Awaiting Institution Decision

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
Awaiting Institution Decision

§ 103 challenge
Y: Claims 1-7

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Awaiting Institution Decision

IPR Status
Awaiting Institution Decision

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

BPCIA
Y

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Leah Watson Robert S. Schwartz, Ph.D.
March 26, 2026
Janssen Files First BPCIA Suit Over Simponi® (golimumab) Biosimilar
Robert S. Schwartz, Ph.D. Leah Watson
March 6, 2026
Bio-Thera Submits aBLA for Simponi® (golimumab) Biosimilar BAT2506
July 24, 2025

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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