BLA number
761099
FDA Purple Book product · Biosimilar 351(k)
Zirabev
bevacizumab-bvzr
Zirabev, BLA 761099, is listed in the FDA Purple Book as a 351(k) biosimilar. This page consolidates 2 exact FDA presentation rows, and FDA names Avastin 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 761099 2 presentationsRxLicensed Pfizer Inc.
Approved
Jun 27, 2019
License type
351(k) Biosimilar
Marketing
Rx
Listed patents
22
Zirabev (bevacizumab-bvzr) is a Biosimilar 351(k) referencing bevacizumab, licensed under a 351(k) BLA in 2019; the Purple Book lists Pfizer Inc. as the BLA applicant, not necessarily the manufacturer or commercial supplier. The Purple Book lists 22 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) biosimilar
Applicant
Pfizer Inc.
Applicant is not automatically the physical manufacturer.
Presentations
2
Exact FDA presentation rows under this BLA.
Approval
Jun 27, 2019
Reference product
Avastin
Zirabev is an FDA-licensed biosimilar without an interchangeability designation in this record.
Zirabev was licensed through the 351(k) pathway as biosimilar to Avastin.
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.
Jun 27, 2019
7 yr 5 mo ago
Today
Strengths & presentations
2 FDA presentation rows · BLA 761099
Strength
100MG/4ML (25MG/ML)
Dosage form
Injection
Route
Intravenous
Presentation
Single-Dose Vial
Center
CDER
License number
2001
Product number
001
Submission type
Original
Supplement number
Not listed
Change type
Not listed
Strength
400MG/16ML (25MG/ML)
Dosage form
Injection
Route
Intravenous
Presentation
Single-Dose Vial
Center
CDER
License number
2001
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/4ML (25MG/ML) | Injection | Intravenous | Single-Dose Vial | Licensed | Rx |
| 002 | 400MG/16ML (25MG/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
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
Zirabev names Avastin 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 Avastin
Reference-family comparison
| Product | Designation | BLA | Approved | Presentation | Marketing |
|---|---|---|---|---|---|
| Avastinbevacizumab | 351(a) name-matched reference candidate | 125085 | Feb 26, 2004 | 100MG/4ML (25MG/ML) · Intravenous | Rx |
| Zirabevbevacizumab-bvzr | 351(k) biosimilar | 761099 | Jun 27, 2019 | 100MG/4ML (25MG/ML) · Intravenous | Rx |
Published patents
BPCIA patent list
| Patent | Expires | In | Source |
|---|---|---|---|
| 9,795,672 | May 28, 2024 | 2 yr 5 mo ago | FDA |
| 7,485,704 | Mar 08, 2025 | 1 yr 7 mo ago | FDA |
| 10,906,986 | Jul 08, 2028 | in 1 yr 9 mo | FDA |
| 11,078,294 | Jul 08, 2028 | in 1 yr 9 mo | FDA |
| 8,574,869 | Jul 08, 2028 | in 1 yr 9 mo | FDA |
| 8,460,895 | Aug 08, 2029 | in 2 yr 10 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 |
| 10,011,856 | May 26, 2031 | in 4 yr 8 mo | FDA |
| 10,662,237 | Aug 07, 2031 | in 4 yr 11 mo | FDA |
| 10,704,071 | Aug 18, 2031 | in 4 yr 11 mo | FDA |
| 9,487,809 | Jan 14, 2032 | in 5 yr 4 mo | FDA |
| 10,513,697 | Sep 17, 2032 | in 6 yr | FDA |
| 10,906,934 | Oct 12, 2033 | in 7 yr 1 mo | FDA |
| 10,017,732 | Mar 14, 2034 | in 7 yr 6 mo | FDA |
| 10,676,710 | Mar 14, 2034 | in 7 yr 6 mo | FDA |
| 10,829,732 | Mar 14, 2034 | in 7 yr 6 mo | FDA |
| 9,441,035 | Apr 23, 2034 | in 7 yr 8 mo | FDA |
| 10,274,466 | Jul 11, 2035 | in 8 yr 11 mo | FDA |
| 10,208,355 | Jul 14, 2035 | in 8 yr 11 mo | FDA |
| 10,336,983 | Jul 31, 2035 | in 8 yr 11 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 Intravenous and Injection; these are regulatory presentation fields, not dosing instructions.
Applicant boundary
Pfizer 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
Zirabev 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 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
- v7Oct 08, 2026
- v6Oct 08, 2026
- v5Sep 21, 2026
- v4Aug 11, 2026
- v3Jul 02, 2026
- v2Jul 02, 2026
Zirabev: 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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