infliximab (Remicade)
infliximab is an FDA-licensed reference biologic from Janssen Biotech, Inc., with 4 approved follow-on biologics. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
4
Biosimilars
0
Interchangeables
0
Listed patents
1998
Reference approved
Reference product
Remicade infliximab
Janssen Biotech, Inc.
- Approved
- Aug 24, 1998
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Molecular structure
Experimental 3D structure for infliximab from the RCSB Protein Data Bank (PDB 5VH3).
Interactive biological assembly from PDB entry 5VH3. Drag to rotate, scroll to zoom, and inspect the full atomic structure right here — no need to leave the page.
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for infliximab, in chronological order.
Reference approval
Approval date of the reference infliximab product.
28 yr 2 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
7 yr 10 mo ago
Biosimilars & interchangeables for infliximab
4 FDA-licensed follow-on biologics referencing infliximab.
| Product | Proper name | Applicant | Type | BLA | Approved |
|---|---|---|---|---|---|
| Inflectra | infliximab-dyyb | CELLTRION, Inc. | Biosimilar 351(k) | 125544 | Apr 05, 2016 |
| Renflexis | infliximab-abda | Samsung Bioepis Co., Ltd. | Biosimilar 351(k) | 761054 | Apr 21, 2017 |
| Ixifi | infliximab-qbtx | Pfizer Ireland Pharmaceuticals Unlimited Company | Biosimilar 351(k) | 761072 | Dec 13, 2017 |
| Avsola | infliximab-axxq | Amgen Inc. | Biosimilar 351(k) | 761086 | Dec 06, 2019 |
Frequently asked questions
What biosimilars are approved for infliximab (Remicade)?
The FDA Purple Book lists 4 approved follow-on biologics referencing infliximab: Inflectra, Renflexis, Ixifi, and Avsola. Of these, 0 are interchangeable biosimilars and 4 are 351(k) biosimilars.
Who makes infliximab biosimilars?
Companies with FDA-approved follow-on biologics referencing infliximab include CELLTRION, Inc., Samsung Bioepis Co., Ltd., Pfizer Ireland Pharmaceuticals Unlimited Company, and Amgen Inc..
Explore the full FDA Purple Book
Search every FDA-licensed biologic, biosimilar, and interchangeable with exclusivity timelines and patent records.