Purple Book product · Biosimilar 351(k)
Herzuma
trastuzumab-pkrb
May 16, 2019
Approved
Biosimilar 351(k)
License type
Rx
Marketing
4
Listed patents
Sourced from the FDA Purple Book · verified Jul 02, 2026
Key dates
Approval
Approval date of this BLA submission.
May 16, 2019
7 yr 3 mo ago
Today
Pharmaceutical detail
Strength
150MG
Dosage form
For injection
Route
Intravenous
Presentation
Single-Dose Vial
Center
CDER
License number
1996
Product number
002
Submission type
Supplement
Supplement number
1
Change type
Not listed
Reference product family
View full familyBiosimilar of trastuzumab (Herceptin)
Patent list (4)
Source provenance
- advanced-searchAdvanced Search · Jul 02, 2026
- monthly-downloadMonthly download · Jul 02, 2026
Change history
- v4Jul 02, 2026
- v3Jul 02, 2026
- v2Jul 02, 2026
Frequently asked questions
When do Herzuma's patents expire?
The FDA Purple Book lists 4 published patents for Herzuma, with the last listed patent expiring Aug 07, 2031. Every patent below links to its FDA source record so you can verify the expiration date.
Is Herzuma a biosimilar?
Yes. Herzuma is a Biosimilar 351(k) referencing trastuzumab, licensed under a 351(k) BLA.
Is Herzuma interchangeable?
Herzuma 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 Herzuma's BLA number?
Herzuma is licensed under BLA 761091, held by CELLTRION, Inc..
When was Herzuma approved by the FDA?
Herzuma was approved by the FDA on May 16, 2019.
Related FDA reference tools
- FDA Orange BookApproved drugs, generics, therapeutic-equivalence codes, patents, and exclusivity.
- FDA BiosimilarsThe list of FDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 & Inspection DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
