Purple Book product · Biosimilar 351(k)
Hercessi
trastuzumab-strf
Apr 25, 2024
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.
Apr 25, 2024
2 yr 3 mo ago
Today
Pharmaceutical detail
Strength
150MG
Dosage form
For Injection
Route
Intravenous
Presentation
Single-Dose Vial
Center
CDER
License number
2105
Product number
001
Submission type
Original
Supplement number
Not listed
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 Hercessi's patents expire?
The FDA Purple Book lists 4 published patents for Hercessi, 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 Hercessi a biosimilar?
Yes. Hercessi is a Biosimilar 351(k) referencing trastuzumab, licensed under a 351(k) BLA.
Is Hercessi interchangeable?
Hercessi 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 Hercessi's BLA number?
Hercessi is licensed under BLA 761346, held by Accord BioPharma Inc..
When was Hercessi approved by the FDA?
Hercessi was approved by the FDA on Apr 25, 2024.
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.
