Simponi® (golimumab)

BL 125289

Simponi® (golimumab)

BL 125289

U.S. License Holder:

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

Date of License:

April-24-2009

Last Update:

Sep-30-2025

approved_indications 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).

approved_indications aBLA / 505(b)(2) Activity

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

AVT05: Alvotech / Teva (January-2025) BAT2506: Bio-Thera (July-2025)

approved_indications Approved Foreign Follow-On Biologics / Biosimilars

Biosimilars Approved In Japan

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

approved_indications U.S. Patent Litigations

PACER

Case No(s):

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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