Purple Book product · Biosimilar 351(k)

Zirabev

bevacizumab-bvzr

351(k) BiosimilarBLA 761099RxLicensed Pfizer Inc.

View bevacizumab family Label PDF Open on FDA Purple Book

Jun 27, 2019

Approved

Biosimilar 351(k)

License type

Marketing

Listed patents

Zirabev (bevacizumab-bvzr) is a Biosimilar 351(k) referencing bevacizumab, licensed under a 351(k) BLA in 2019 and marketed by Pfizer Inc.. The Purple Book lists 22 published patents for this product.

Sourced from the FDA Purple Book · verified Jul 02, 2026

Key dates

Approval
Approval date of this BLA submission.
Jun 27, 2019
7 yr 2 mo ago
Today

Pharmaceutical detail

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

Reference product family

View full family

Biosimilar of bevacizumab (Avastin)

Patent list (22)

Patents published in the FDA Purple Book Patent List for this product, with expiration date and source link.
Patent	Expires	In	Source
9,795,672	May 28, 2024	2 yr 2 mo ago	FDA
7,485,704	Mar 08, 2025	1 yr 5 mo ago	FDA
10,906,986	Jul 08, 2028	in 2 yr	FDA
11,078,294	Jul 08, 2028	in 2 yr	FDA
8,574,869	Jul 08, 2028	in 2 yr	FDA
8,460,895	Aug 08, 2029	in 3 yr 1 mo	FDA
10,982,003	Aug 06, 2030	in 4 yr 1 mo	FDA
9,714,293	Aug 06, 2030	in 4 yr 1 mo	FDA
8,512,983	Jan 04, 2031	in 4 yr 6 mo	FDA
10,011,856	May 26, 2031	in 4 yr 11 mo	FDA
10,662,237	Aug 07, 2031	in 5 yr 2 mo	FDA
10,704,071	Aug 18, 2031	in 5 yr 2 mo	FDA
9,487,809	Jan 14, 2032	in 5 yr 7 mo	FDA
10,513,697	Sep 17, 2032	in 6 yr 3 mo	FDA
10,906,934	Oct 12, 2033	in 7 yr 4 mo	FDA
10,017,732	Mar 14, 2034	in 7 yr 9 mo	FDA
10,676,710	Mar 14, 2034	in 7 yr 9 mo	FDA
10,829,732	Mar 14, 2034	in 7 yr 9 mo	FDA
9,441,035	Apr 23, 2034	in 7 yr 11 mo	FDA
10,274,466	Jul 11, 2035	in 9 yr 1 mo	FDA
10,208,355	Jul 14, 2035	in 9 yr 1 mo	FDA
10,336,983	Jul 31, 2035	in 9 yr 2 mo	FDA

Source provenance

Source kind · Advanced Search

Checked Jul 02, 2026

FDA source FDA source

advanced-searchAdvanced Search · Jul 02, 2026
monthly-downloadMonthly download · Jul 02, 2026

Change history

v3Jul 02, 2026
v2Jul 02, 2026

Frequently asked questions

When do Zirabev's patents expire?

The FDA Purple Book lists 22 published patents for Zirabev, with the last listed patent expiring Jul 31, 2035. Every patent below links to its FDA source record so you can verify the expiration date.

Is Zirabev a biosimilar?

Yes. Zirabev is a Biosimilar 351(k) referencing bevacizumab, licensed under a 351(k) BLA.

Is Zirabev interchangeable?

Zirabev is a 351(k) biosimilar but does not carry an interchangeability designation in the Purple Book, so pharmacy-level substitution depends on state law.

What is Zirabev's BLA number?

Zirabev is licensed under BLA 761099, held by Pfizer Inc..

When was Zirabev approved by the FDA?

Zirabev was approved by the FDA on Jun 27, 2019.

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