Simponi

Treats moderately to severely active rheumatoid arthritis. BLA 125289, held by Centocor Ortho Biotech Inc. Golimumab.

As of Nov 13, 2026, BLA 125289 (Simponi), held by Centocor Ortho Biotech Inc, was first approved by FDA on Apr 24, 2009, with 32 approved supplements and 0 published complete response letters.

First approved: Apr 24, 2009
Review: Standard
Supplements approved: 32
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

SIMPONI 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 moderately to severely active ulcerative colitis (UC) 1.1 Rheumatoid Arthritis SIMPONI, in combination with methotrexate, is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis. 1.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 33 submissions below

Date	Submission	Status	Documents
Oct 7, 2025	Supplement 157Efficacy (new indication or use) · Standard review	Approved	Review Label Letter
Jun 22, 2017	Supplement 133Efficacy (new indication or use) · Standard review	Approved	Label Letter Pediatric Medical Review Pediatric Clinical Pharmacology Review
Jan 24, 2014	Supplement 105Efficacy (new indication or use) · Standard review	Approved	None posted
May 15, 2013	Supplement 79Efficacy (new indication or use) · Standard review	Approved	Label Letter
May 15, 2013	Supplement 78Efficacy (new indication or use) · Standard review	Approved	Label Letter
May 15, 2013	Supplement 77Efficacy (new indication or use) · Standard review	Approved	Label Letter
Apr 24, 2009	Original applicationNew molecular entity · Standard review	Approved	Review Summary Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
Simponi50MG · injectable; injection	Golimumab	Rx

All 33 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Oct 22, 2025	Supplement 158Labeling · Standard review	Approved	Letter Label Medication Guide
Oct 7, 2025	Supplement 157Efficacy (new indication or use) · Standard review	Approved	Review Label Letter
Oct 1, 2025	Supplement 156Labeling · Standard review	Approved	Letter Label
Apr 18, 2025	Supplement 155Labeling · Standard review	Approved	Letter Label
Nov 16, 2023	Supplement 153Labeling · Standard review	Approved	Letter
Mar 30, 2023	Supplement 150Labeling · Standard review	Approved	Letter Label
Sep 24, 2019	Supplement 146Labeling · Standard review	Approved	Label Letter
Mar 6, 2018	Supplement 139Labeling · Standard review	Approved	Letter Label
Feb 9, 2018	Supplement 141Labeling · Standard review	Approved	Label Letter
Nov 13, 2017	Supplement 137Labeling · Standard review	Approved	Letter Label
Jun 22, 2017	Supplement 133Efficacy (new indication or use) · Standard review	Approved	Label Letter Pediatric Medical Review Pediatric Clinical Pharmacology Review
Jan 30, 2017	Supplement 135Labeling · Standard review	Approved	Letter Label
Jan 8, 2016	Supplement 127Labeling · Standard review	Approved	Label Letter
Jun 16, 2015	Supplement 124Labeling · Standard review	Approved	Review Label Letter
Dec 19, 2014	Supplement 121Labeling · Standard review	Approved	Letter
Jan 24, 2014	Supplement 105Efficacy (new indication or use) · Standard review	Approved	None posted
Dec 27, 2013	Supplement 103Labeling · Standard review	Approved	Review Letter Label
Nov 13, 2013	Supplement 94Labeling · Standard review	Approved	Label Letter
May 15, 2013	Supplement 79Efficacy (new indication or use) · Standard review	Approved	Label Letter
May 15, 2013	Supplement 78Efficacy (new indication or use) · Standard review	Approved	Label Letter
May 15, 2013	Supplement 77Efficacy (new indication or use) · Standard review	Approved	Label Letter
May 6, 2013	Supplement 86Labeling · Standard review	Approved	Letter Label
Apr 23, 2013	Supplement 84Labeling · Standard review	Approved	Letter Label
Nov 23, 2012	Supplement 70Labeling · Standard review	Approved	Label Letter
Dec 26, 2011	Supplement 64Labeling · Standard review	Approved	Label Letter
Sep 7, 2011	Supplement 53Labeling · Standard review	Approved	Letter
Aug 17, 2011	Supplement 38Labeling · Standard review	Approved	Letter Label
Mar 17, 2011	Supplement 20Labeling · Standard review	Approved	Letter
Dec 22, 2010	Supplement 29Labeling · Standard review	Approved	Letter Label
Sep 29, 2010	Supplement 33Labeling · Standard review	Approved	Letter
Jul 29, 2010	Supplement 25Labeling · Standard review	Approved	Label Letter
Nov 18, 2009	Supplement 6Labeling · Standard review	Approved	Label Letter
Apr 24, 2009	Original applicationNew molecular entity · Standard review	Approved	Review Summary Review Letter Label

Identifiers

Application: BLA 125289
Drugs@FDA: Overview at FDA
Company: Centocor Ortho Biotech Inc.

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters