BLA number
761452
FDA Purple Book product · Interchangeable
Immgolis Intri
golimumab-sldi
Immgolis Intri, BLA 761452, is listed in the FDA Purple Book as a 351(k) interchangeable biosimilar. This page consolidates 1 exact FDA presentation row, and FDA names Simponi Aria 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 761452RxLicensed Accord BioPharma Inc.
Approved
May 15, 2026
License type
351(k) Interchangeable
Marketing
Rx
Listed patents
26
Immgolis Intri (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
Regulatory role
351(k) interchangeable biosimilar
Applicant
Accord BioPharma Inc.
Applicant is not automatically the physical manufacturer.
Presentations
1
Exact FDA presentation rows under this BLA.
Approval
May 15, 2026
Reference product
Simponi Aria
Immgolis Intri is an FDA-designated interchangeable biosimilar.
Immgolis Intri is a 351(k) biosimilar of Simponi Aria 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
Pharmaceutical detail
FDA product record
Strength
50MG/4ML (12.5MG/ML)
Dosage form
Injection
Route
Intravenous
Presentation
Single-Dose Vial
Center
CDER
License number
2105
Product number
003
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.
| Product | Strength | Dosage form | Route | Presentation | Licensure | Marketing |
|---|---|---|---|---|---|---|
| 003 | 50MG/4ML (12.5MG/ML) | Injection | Intravenous | Single-Dose Vial | 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.
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 candidateFDA 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
Immgolis Intri names Simponi Aria 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 Aria
Reference-family comparison
| 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 |
| Immgolis Intrigolimumab-sldi | 351(k) interchangeable biosimilar | 761452 | May 15, 2026 | 50MG/4ML (12.5MG/ML) · Intravenous | Rx |
Published patents
BPCIA patent list
| Patent | Expires | In | Source |
|---|---|---|---|
| 8,017,325 | Jan 13, 2029 | in 2 yr 3 mo | FDA |
| 8,017,325 | Jan 13, 2029 | in 2 yr 3 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
1 exact FDA presentation row is consolidated under this BLA rather than split across duplicate pages.
Administration fields
The loaded rows list Intravenous 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 Intri 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, 2026FDA release · September 2026
- 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 Intri: 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.
Related FDA reference tools
- FDA Orange BookApproved drugs, generics, therapeutic-equivalence codes, patents, and exclusivity.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
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