etanercept (Enbrel)
etanercept is an FDA-licensed reference biologic from Immunex Corporation, with 2 approved follow-on biologics. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
2
Biosimilars
0
Interchangeables
0
Listed patents
2007
Reference approved
Reference product
Enbrel etanercept
Immunex Corporation
- Approved
- Feb 01, 2007
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for etanercept, in chronological order.
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
20 yr 4 mo ago
Reference approval
Approval date of the reference etanercept product.
19 yr 7 mo ago
Biosimilars & interchangeables for etanercept
2 FDA-licensed follow-on biologics referencing etanercept.
| Product | Proper name | Applicant | Type | BLA | Approved |
|---|---|---|---|---|---|
| Erelzi | etanercept-szzs | Sandoz Inc. | Biosimilar 351(k) | 761042 | Aug 30, 2016 |
| Eticovo | etanercept-ykro | Samsung Bioepis Co., Ltd. | Biosimilar 351(k) | 761066 | May 03, 2024 |
Frequently asked questions
What biosimilars are approved for etanercept (Enbrel)?
The FDA Purple Book lists 2 approved follow-on biologics referencing etanercept: Erelzi and Eticovo. Of these, 0 are interchangeable biosimilars and 2 are 351(k) biosimilars.
Who makes etanercept biosimilars?
Companies with FDA-approved follow-on biologics referencing etanercept include Sandoz Inc. and Samsung Bioepis Co., Ltd..
Explore the full FDA Purple Book
Search every FDA-licensed biologic, biosimilar, and interchangeable with exclusivity timelines and patent records.