Purple Book product · Biosimilar 351(k)
Eticovo
etanercept-ykro
May 03, 2024
Approved
Biosimilar 351(k)
License type
Disc
Marketing
None
Listed patents
Sourced from the FDA Purple Book · verified Jul 02, 2026
Key dates
Approval
Approval date of this BLA submission.
May 03, 2024
2 yr 3 mo ago
Today
Pharmaceutical detail
Strength
50MG/ML
Dosage form
Injection
Route
Subcutaneous
Presentation
Autoinjector
Center
CDER
License number
2046
Product number
003
Submission type
Supplement
Supplement number
1
Change type
Not listed
Reference product family
View full familyBiosimilar of etanercept (Enbrel)
Patent list
No patent-list records were published for this product. The Purple Book patent list reflects the statutory patent exchange under the BPCIA and is not exhaustive.
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
Is Eticovo a biosimilar?
Yes. Eticovo is a Biosimilar 351(k) referencing etanercept, licensed under a 351(k) BLA.
Is Eticovo interchangeable?
Eticovo 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 Eticovo's BLA number?
Eticovo is licensed under BLA 761066, held by Samsung Bioepis Co., Ltd..
When was Eticovo approved by the FDA?
Eticovo was approved by the FDA on May 03, 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.
