What is Immgolis in the FDA Purple Book?

Immgolis, BLA 761452, is listed as a 351(k) interchangeable biosimilar with 2 exact FDA presentation rows. The page preserves the BLA-level regulatory role and does not substitute clinical, inventory, or legal conclusions for the source record.

Who is responsible for BLA 761452?

Immgolis, BLA 761452, lists Accord BioPharma Inc. as the BLA applicant. The applicant field identifies responsibility for the application; it does not, by itself, prove that the organization physically manufactures, labels, distributes, or currently sells every presentation.

What presentations are listed for Immgolis?

Immgolis, BLA 761452, has 2 exact FDA presentation rows consolidated on this page. Strength, dosage form, route, product number, licensure, and marketing fields remain attached to their own row rather than being merged into disconnected lists.

What is Immgolis's reference-product relationship?

Immgolis, BLA 761452, lists Simponi as its FDA reference product. The loaded row does not supply a reference BLA number, so this page does not invent one from a name match.

When was Immgolis licensed by FDA?

Immgolis, BLA 761452, has a listed FDA approval date of May 15, 2026. The date is reproduced from this exact Purple Book BLA record and is not a statement about commercial launch or current availability.

Does this page summarize Immgolis's FDA label?

Immgolis, BLA 761452, FDA exposes a label link on this Purple Book row, but labeling content remains unavailable until the document is independently matched to this exact BLA and its presentations. Therefore the page does not publish product-specific approved uses, dosing, boxed warnings, or safety claims from a reference product or same-ingredient document.

What patent information is published for Immgolis?

Immgolis, BLA 761452, has 26 published Purple Book patent rows, with the latest listed expiration on May 03, 2039. FDA publishes sponsor-provided patent information ministerially; these rows are not conclusions about validity, infringement, freedom to operate, or market entry.

What exclusivity information is listed for Immgolis?

Immgolis, BLA 761452, has no populated exclusivity date in the loaded Purple Book row. Missing database fields do not prove that no regulatory or legal constraints exist, and this page does not calculate a market-entry date.

FDA Purple Book product · Interchangeable

Immgolis

golimumab-sldi

Immgolis, BLA 761452, is listed in the FDA Purple Book as a 351(k) interchangeable biosimilar. This page consolidates 2 exact FDA presentation rows, and FDA names Simponi as its reference product. It separates the BLA applicant from any unverified manufacturer and does not infer clinical labeling, pharmacy substitution, commercial availability, or patent conclusions.

351(k) InterchangeableBLA 761452 2 presentationsRxLicensed Accord BioPharma Inc.

Approved

May 15, 2026

License type

351(k) Interchangeable

Marketing

Listed patents

Immgolis (golimumab-sldi) is a Interchangeable referencing golimumab, licensed under a 351(k) BLA in 2026; the Purple Book lists Accord BioPharma Inc. as the BLA applicant, not necessarily the manufacturer or commercial supplier. Its interchangeable biosimilar designation may permit pharmacy-level substitution for the reference product without prescriber intervention, subject to state law; it is not a superiority claim. The Purple Book lists 26 published patents for this product.

Sourced from the FDA Purple Book · verified Oct 08, 2026

What this Purple Book record establishes

Regulatory interpretation

BLA number

761452

Regulatory role

351(k) interchangeable biosimilar

Applicant

Accord BioPharma Inc.

Applicant is not automatically the physical manufacturer.

Presentations

Exact FDA presentation rows under this BLA.

Approval

May 15, 2026

Reference product

Simponi

Immgolis is an FDA-designated interchangeable biosimilar.

Immgolis is a 351(k) biosimilar of Simponi and carries an interchangeability designation.

Substitution boundary

An interchangeable designation may permit pharmacy-level substitution for the reference product without prescriber intervention, depending on state pharmacy law; it is not a claim of clinical superiority.

Key dates

Licensure & exclusivity

Approval
Approval date of this BLA submission.
May 15, 2026
5 mo ago
Today

Strengths & presentations

2 FDA presentation rows · BLA 761452

Strength

50MG/0.5ML (100MG/ML)

Dosage form

Injection

Route

Subcutaneous

Presentation

Pre-Filled Syringe

Center

CDER

License number

2105

Product number

001

Submission type

Original

Supplement number

Not listed

Change type

Not listed

Exact presentation matrix

One row per FDA presentation under this exact BLA. Missing cells remain unavailable rather than being borrowed from another product.

Exact FDA Purple Book presentation rows for this BLA
Product	Strength	Dosage form	Route	Presentation	Licensure	Marketing
001	50MG/0.5ML (100MG/ML)	Injection	Subcutaneous	Pre-Filled Syringe	Licensed	Rx
002	100MG/ML	Injection	Subcutaneous	Pre-Filled Syringe	Licensed	Rx

Other brands under BLA 761452

The rows above are this brand's presentations. FDA also lists the brand below on this BLA, each with its own presentation rows. Strength and reference product come from each brand's own rows; a shared BLA does not establish shared presentations, approved uses, or substitutability.

Immgolis Intri
golimumab-sldi · Reference product: Simponi Aria · Strength: 50MG/4ML (12.5MG/ML)

Exact-source evidence coverage

Labeling & approval review

Current product label

Candidate awaiting exact-BLA match

FDA exposes a label link on this Purple Book row, but labeling content remains unavailable until the document is independently matched to this exact BLA and its presentations.

Inspect FDA label candidate

FDA approval evidence

Exact-source research required

No independently matched exact-BLA FDA approval letter or review package is stored, so product-specific biosimilarity or switching evidence is not summarized.

Human review pending

Automated BLA-level interpretation has not been marked human-reviewed. The research queue contains 2 exact-source tasks. Labeling and approval-review claims stay unavailable until their own match gate passes.

Reference product family

Biosimilars & interchangeables

View full family

Immgolis names Simponi as its reference product. The comparison below shows locally matched BLA candidates and follow-ons; it does not invent a reference BLA number when FDA did not state one in the loaded row.

Biosimilar of Simponi

Reference-family comparison

Purple Book comparison of products in this reference family
Product	Designation	BLA	Approved	Presentation	Marketing
Simponigolimumab	351(a) ambiguous reference candidate	125289	Apr 24, 2009	50MG/0.5ML · Subcutaneous	Rx
Simponi Ariagolimumab	351(a) ambiguous reference candidate	125433	Jul 18, 2013	50MG/4ML (12.5MG/ML) · Intravenous	Rx
Immgolisgolimumab-sldi	351(k) interchangeable biosimilar	761452	May 15, 2026	50MG/0.5ML (100MG/ML) · Subcutaneous	Rx

Published patents

BPCIA patent list

Patents published in the FDA Purple Book Patent List for this product, with expiration date and source link.
Patent	Expires	In	Source
8,017,325	Jan 13, 2029	in 2 yr 4 mo	FDA
8,017,325	Jan 13, 2029	in 2 yr 4 mo	FDA
10,500,348	Nov 20, 2031	in 5 yr 2 mo	FDA
9,170,249	Mar 12, 2032	in 5 yr 6 mo	FDA
9,170,249	Mar 12, 2032	in 5 yr 6 mo	FDA
9,890,410	Mar 12, 2032	in 5 yr 6 mo	FDA
9,890,410	Mar 12, 2032	in 5 yr 6 mo	FDA
12,139,735	Jul 06, 2032	in 5 yr 10 mo	FDA
12,139,735	Jul 06, 2032	in 5 yr 10 mo	FDA
8,852,889	Jul 06, 2032	in 5 yr 10 mo	FDA
8,852,889	Jul 06, 2032	in 5 yr 10 mo	FDA
9,475,858	Jul 06, 2032	in 5 yr 10 mo	FDA
9,475,858	Jul 06, 2032	in 5 yr 10 mo	FDA
11,633,546	Nov 08, 2032	in 6 yr 2 mo	FDA
8,956,830	Mar 14, 2033	in 6 yr 6 mo	FDA
8,956,830	Mar 14, 2033	in 6 yr 6 mo	FDA
9,217,168	Mar 14, 2033	in 6 yr 6 mo	FDA
9,217,168	Mar 14, 2033	in 6 yr 6 mo	FDA
9,487,810	Mar 14, 2033	in 6 yr 6 mo	FDA
9,487,810	Mar 14, 2033	in 6 yr 6 mo	FDA
9,663,810	Mar 14, 2033	in 6 yr 6 mo	FDA
9,663,810	Mar 14, 2033	in 6 yr 6 mo	FDA
10,421,986	Aug 08, 2035	in 8 yr 11 mo	FDA
10,421,986	Aug 08, 2035	in 8 yr 11 mo	FDA
11,225,516	May 03, 2039	in 12 yr 9 mo	FDA
11,225,516	May 03, 2039	in 12 yr 9 mo	FDA

Practical characteristics and limits

Source-bounded interpretation

Presentation coverage

2 exact FDA presentation rows are consolidated under this BLA rather than split across duplicate pages.

Administration fields

The loaded rows list Subcutaneous and Injection; these are regulatory presentation fields, not dosing instructions.

Applicant boundary

Accord BioPharma Inc. is the listed BLA applicant. The page does not relabel the applicant as manufacturer, labeler, distributor, or commercial supplier without an exact product-specific source.

Regulatory comparison

Immgolis is an FDA-designated interchangeable biosimilar. Family comparisons preserve each BLA's own designation and do not use Orange Book therapeutic-equivalence terminology.

Source provenance

FDA Purple Book data

Source kind · Monthly download

Checked Oct 08, 2026

FDA release · September 2026

FDA source FDA source FDA source

advanced-searchAdvanced Search · Oct 08, 2026
monthly-downloadMonthly download · Oct 08, 2026
monthly-downloadMonthly download · Sep 21, 2026

What this record does not establish

Purple Book marketing status is a regulatory field, not real-time commercial inventory or launch status.
The listed applicant or BLA holder is not automatically the product’s physical manufacturer, labeler, or distributor.
Biosimilar status and interchangeability are distinct FDA designations; neither is a therapeutic-equivalence code from the Orange Book.
A missing patent or exclusivity row is not proof that no relevant rights exist, and listed patent information is not a freedom-to-operate opinion.
Approved uses, dosing, warnings, and clinical evidence require the exact current product label or approval package and are not inferred from the reference product.

Change history

Record versions

v3Oct 08, 2026
v2Oct 08, 2026
v1Sep 21, 2026

Immgolis: frequently asked questions

Licensure, biosimilar status, exclusivity, and patents for this biologic, from the FDA Purple Book.

Built directly from the FDA Purple Book database of licensed biological products. License types, approval and exclusivity dates, and the patent list match the official FDA record. The Purple Book patent list reflects the statutory BPCIA patent exchange and is not exhaustive.

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