BLA number
125433
FDA Purple Book product · 351(a) biologic
Simponi Aria
golimumab
Simponi Aria, BLA 125433, is listed in the FDA Purple Book as a 351(a) reference biologic. This page consolidates 1 exact FDA presentation row, and 2 FDA rows name-link 351(k) follow-on products to its reference family. It separates the BLA applicant from any unverified manufacturer and does not infer clinical labeling, pharmacy substitution, commercial availability, or patent conclusions.
351(a)BLA 125433RxLicensed Janssen Biotech, Inc.
Approved
Jul 18, 2013
License type
351(a)
Marketing
Rx
Listed patents
26
Simponi Aria (golimumab) is Janssen Biotech, Inc.'s FDA-licensed 351(a) biologic under BLA 125433, approved in 2013. The FDA Purple Book lists 26 published patents for it, the last expiring 2039. 2 distinct approved follow-on biologics explicitly reference Simponi Aria (Immgolis and Immgolis Intri), making its reference-product role visible in the loaded family data.
Sourced from the FDA Purple Book · verified Oct 08, 2026
What this Purple Book record establishes
Regulatory interpretation
Regulatory role
351(a) reference biologic
Applicant
Janssen Biotech, Inc.
Applicant is not automatically the physical manufacturer.
Presentations
1
Exact FDA presentation rows under this BLA.
Approval
Jul 18, 2013
Follow-on biologics
2
Simponi Aria is a 351(a) reference biologic supported by exact-BLA evidence.
2 distinct licensed follow-on biologics in the loaded Purple Book data name Simponi Aria as their reference product; exact-BLA patent or exclusivity fields, or an unambiguous single-BLA name match, support this page's role.
Substitution boundary
Substitution status belongs to an individual follow-on product; it cannot be inferred from the reference product alone.
Key dates
Licensure & exclusivity
Approval
Approval date of this BLA submission.
Jul 18, 2013
13 yr 5 mo ago
Today
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
Sep 29, 2027
in 1 yr
Pharmaceutical detail
FDA product record
Strength
50MG/4ML (12.5MG/ML)
Dosage form
Injection
Route
Intravenous
Presentation
Single-Dose Vial
Center
CDER
License number
1864
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.
| Product | Strength | Dosage form | Route | Presentation | Licensure | Marketing |
|---|---|---|---|---|---|---|
| 001 | 50MG/4ML (12.5MG/ML) | Injection | Intravenous | Single-Dose Vial | Licensed | Rx |
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
Not applicable to 351(a)
A biosimilar totality-of-evidence summary is not applicable to this 351(a) record. Product-specific clinical content still requires an exact-BLA label or review source.
Human review pending
Automated BLA-level interpretation has not been marked human-reviewed. The research queue contains 1 exact-source task. Labeling and approval-review claims stay unavailable until their own match gate passes.
Reference product family
Biosimilars & interchangeables
2 distinct 351(k) follow-on biologics are linked through FDA-stated reference names to Simponi Aria; 2 are designated interchangeable and 2 have a licensed status in the loaded snapshot.
Exact-BLA patent, exclusivity, or unambiguous linked-family evidence supports this page's reference role. Name-linked licensed biosimilars and interchangeables are listed below.
- 2026ImmgolisInterchangeable
golimumab-sldi · Accord BioPharma Inc.
- 2026Immgolis IntriInterchangeable
golimumab-sldi · Accord BioPharma Inc.
Reference-family comparison
| Product | Designation | BLA | Approved | Presentation | Marketing |
|---|---|---|---|---|---|
| Simponi Ariagolimumab | 351(a) reference biologic | 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 |
| 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 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
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
Janssen Biotech, 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
Simponi Aria is a 351(a) reference biologic supported by exact-BLA evidence. 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
- advanced-searchAdvanced Search · Jul 02, 2026
- monthly-downloadMonthly download · Jul 02, 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
- v8Oct 08, 2026
- v7Oct 08, 2026
- v6Sep 21, 2026
- v5Aug 11, 2026
- v4Jul 02, 2026
- v3Jul 02, 2026
- v2Jul 02, 2026
Simponi Aria: 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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