BLA number
761088
FDA Purple Book product · Biosimilar 351(k)
Truxima
rituximab-abbs
Truxima, BLA 761088, is listed in the FDA Purple Book as a 351(k) biosimilar. This page consolidates 2 exact FDA presentation rows, and FDA names Rituxan 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) BiosimilarBLA 761088 2 presentationsRxLicensed CELLTRION, Inc.
Approved
Nov 28, 2018
License type
351(k) Biosimilar
Marketing
Rx
Listed patents
15
Truxima (rituximab-abbs) is a Biosimilar 351(k) referencing rituximab, licensed under a 351(k) BLA in 2018; the Purple Book lists CELLTRION, Inc. as the BLA applicant, not necessarily the manufacturer or commercial supplier. The Purple Book lists 15 published patents for this product.
Sourced from the FDA Purple Book · verified Aug 11, 2026
What this Purple Book record establishes
Regulatory interpretation
Regulatory role
351(k) biosimilar
Applicant
CELLTRION, Inc.
Applicant is not automatically the physical manufacturer.
Presentations
2
Exact FDA presentation rows under this BLA.
Approval
Nov 28, 2018
Reference product
Rituxan
Truxima is an FDA-licensed biosimilar without an interchangeability designation in this record.
Truxima was licensed through the 351(k) pathway as biosimilar to Rituxan.
Substitution boundary
Biosimilar status alone is not an FDA interchangeability designation and does not establish automatic pharmacy substitution.
Key dates
Licensure & exclusivity
Approval
Approval date of this BLA submission.
Nov 28, 2018
7 yr 11 mo ago
Today
Strengths & presentations
2 FDA presentation rows · BLA 761088
Strength
100MG/10ML (10MG/ML)
Dosage form
Injection
Route
Intravenous
Presentation
Single-Dose Vial
Center
CDER
License number
1996
Product number
001
Submission type
Original
Supplement number
Not listed
Change type
Not listed
Strength
500MG/50ML (10MG/ML)
Dosage form
Injection
Route
Intravenous
Presentation
Single-Dose Vial
Center
CDER
License number
1996
Product number
002
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 | 100MG/10ML (10MG/ML) | Injection | Intravenous | Single-Dose Vial | Licensed | Rx |
| 002 | 500MG/50ML (10MG/ML) | Injection | Intravenous | Single-Dose Vial | Licensed | Rx |
Exact-source evidence coverage
Labeling & approval review
Current product label
Exact-source research required
No exact-BLA label candidate is stored for this record. Approved uses, dosing, and warnings are intentionally unavailable and queued for exact-source research.
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
Truxima names Rituxan 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 Rituxan
Reference-family comparison
| Product | Designation | BLA | Approved | Presentation | Marketing |
|---|---|---|---|---|---|
| Rituxanrituximab | 351(a) ambiguous reference candidate | 103705 | Nov 26, 1997 | 100MG/10ML (10MG/ML) · Intravenous | Rx |
| Rituxanrituximab | 351(a) ambiguous reference candidate | 103737 | Feb 19, 2002 | 100MG/10ML (10MG/ML) · Intravenous | Disc |
| Truximarituximab-abbs | 351(k) biosimilar | 761088 | Nov 28, 2018 | 500MG/50ML (10MG/ML) · Intravenous | Rx |
Published patents
BPCIA patent list
| Patent | Expires | In | Source |
|---|---|---|---|
| 7,485,704 | Mar 08, 2025 | 1 yr 7 mo ago | FDA |
| 7,976,838 | Jun 30, 2025 | 1 yr 3 mo ago | FDA |
| 10,450,379 | Nov 14, 2026 | in 2 mo | FDA |
| 10,654,940 | Nov 14, 2026 | in 2 mo | FDA |
| 10,759,866 | Jul 08, 2028 | in 1 yr 10 mo | FDA |
| 8,574,869 | Jul 08, 2028 | in 1 yr 10 mo | FDA |
| 8,460,895 | Aug 08, 2029 | in 2 yr 11 mo | FDA |
| 10,982,003 | Aug 06, 2030 | in 3 yr 11 mo | FDA |
| 9,714,293 | Aug 06, 2030 | in 3 yr 11 mo | FDA |
| 8,512,983 | Jan 04, 2031 | in 4 yr 4 mo | FDA |
| 10,662,237 | Aug 07, 2031 | in 4 yr 11 mo | FDA |
| 10,017,732 | Mar 14, 2034 | in 7 yr 7 mo | FDA |
| 10,676,710 | Mar 14, 2034 | in 7 yr 7 mo | FDA |
| 10,829,732 | Mar 14, 2034 | in 7 yr 7 mo | FDA |
| 10,336,983 | Jul 31, 2035 | in 9 yr | 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 Intravenous and Injection; these are regulatory presentation fields, not dosing instructions.
Applicant boundary
CELLTRION, 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
Truxima is an FDA-licensed biosimilar without an interchangeability designation in this record. 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 Aug 11, 2026FDA release · June 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
- v5Aug 11, 2026
- v4Jul 02, 2026
- v3Jul 02, 2026
- v2Jul 02, 2026
Truxima: 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.
