Viewing data from:

IMMGOLIS

Interchangeable Biosimilar

GOLIMUMAB-SLDI | B761452 | ACCORD BIOPHARMA INC.

3 products0 Purple Book patents3 biosimilars

Biologic LOEBiosimilar competition

3 approved biosimilars

May 15, 2038(4210 days remaining)

Regulatory Exclusivities

Type	Expiry	Status	Source
12-Year BPCIA	May. 15, 2038	Active	Computed

Purple Book Patents

No listed patents in Purple Book.

Approved Biosimilars

ImmgolisBLA 761452ICImmgolisBLA 761452ICImmgolis IntriBLA 761452IC

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Purple Book (Biologics)

BLA 761452 | 3 presentations

InterchangeableLicensedCDERInjection

Proper Name

golimumab-sldi

Applicant

Accord BioPharma Inc.

Approval Date

May 15, 2026

Reference Product: Simponi — golimumab

Presentations

50MG/0.5ML (100MG/ML) — Pre-Filled Syringe (Subcutaneous)

100MG/ML — Pre-Filled Syringe (Subcutaneous)

50MG/4ML (12.5MG/ML) — Single-Dose Vial (Intravenous)

Source: FDA Purple Book (purplebooksearch.fda.gov).

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
May 18, 2026	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 50MG/0.5ML

▴

INJECTION;SOLUTION | Approved: 2026-05-15 00:00:00

No patent or exclusivity listings for this strength.

#002 — 100MG/1ML

▾

INJECTION;SOLUTION | Approved: 2026-05-15 00:00:00

#003 — 50MG/4ML

▾

INJECTION;SOLUTION | Approved: 2026-05-15 00:00:00