Purple Book product · Biosimilar 351(k)
Inflectra
infliximab-dyyb
Apr 05, 2016
Approved
Biosimilar 351(k)
License type
Rx
Marketing
None
Listed patents
Sourced from the FDA Purple Book · verified Jul 02, 2026
Key dates
Approval
Approval date of this BLA submission.
Apr 05, 2016
10 yr 5 mo ago
Today
Pharmaceutical detail
Strength
100MG
Dosage form
For Injection
Route
Intravenous
Presentation
Single-Dose Vial
Center
CDER
License number
1996
Product number
001
Submission type
Original
Supplement number
Not listed
Change type
Not listed
Reference product family
View full familyBiosimilar of infliximab (Remicade)
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 Inflectra a biosimilar?
Yes. Inflectra is a Biosimilar 351(k) referencing infliximab, licensed under a 351(k) BLA.
Is Inflectra interchangeable?
Inflectra 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 Inflectra's BLA number?
Inflectra is licensed under BLA 125544, held by CELLTRION, Inc..
When was Inflectra approved by the FDA?
Inflectra was approved by the FDA on Apr 05, 2016.
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.
