FDA Purple Book · Reference family
infliximab-dyyb (Zymfentra)
infliximab-dyyb is an FDA-licensed reference biologic from CELLTRION, Inc.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2023
Reference approved
Reference product
351(a)BLA 761358
Zymfentra infliximab-dyyb
CELLTRION, Inc.
- Approved
- Oct 20, 2023
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for infliximab-dyyb, in chronological order.
Reference approval
Approval date of the reference infliximab-dyyb product.
2 yr 8 mo ago
Frequently asked questions
Are there biosimilars approved for infliximab-dyyb (Zymfentra)?
No 351(k) biosimilars or interchangeable biosimilars referencing infliximab-dyyb are listed in the FDA Purple Book yet.
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