Purple Book product · Biosimilar 351(k)
Renflexis
infliximab-abda
Apr 21, 2017
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 21, 2017
9 yr 5 mo ago
Today
Pharmaceutical detail
Strength
100MG
Dosage form
For Injection
Route
Intravenous
Presentation
Single-Dose Vial
Center
CDER
License number
2046
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
- v3Jul 02, 2026
- v2Jul 02, 2026
Frequently asked questions
Is Renflexis a biosimilar?
Yes. Renflexis is a Biosimilar 351(k) referencing infliximab, licensed under a 351(k) BLA.
Is Renflexis interchangeable?
Renflexis 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 Renflexis's BLA number?
Renflexis is licensed under BLA 761054, held by Samsung Bioepis Co., Ltd..
When was Renflexis approved by the FDA?
Renflexis was approved by the FDA on Apr 21, 2017.
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.
