What is Enbrel in the FDA Purple Book?

Enbrel, BLA 103795, is listed as a 351(a) reference biologic with 6 exact FDA presentation rows. The page preserves the BLA-level regulatory role and does not substitute clinical, inventory, or legal conclusions for the source record.

Who is responsible for BLA 103795?

Enbrel, BLA 103795, lists Immunex Corporation as the BLA applicant. The applicant field identifies responsibility for the application; it does not, by itself, prove that the organization physically manufactures, labels, distributes, or currently sells every presentation.

What presentations are listed for Enbrel?

Enbrel, BLA 103795, has 6 exact FDA presentation rows consolidated on this page. Strength, dosage form, route, product number, licensure, and marketing fields remain attached to their own row rather than being merged into disconnected lists.

What is Enbrel's reference-product relationship?

Enbrel, BLA 103795, is supported as a reference biologic by exact-BLA evidence and has 3 name-linked 351(k) follow-on products in the loaded snapshot. This answer is limited to the current FDA Purple Book record and its exact BLA-level fields.

Is Enbrel interchangeable?

Enbrel, BLA 103795, is not presented as an interchangeable product. Interchangeability is an FDA designation attached to an individual 351(k) follow-on, not a property inferred from this 351(a) BLA or its family.

When was Enbrel licensed by FDA?

Enbrel, BLA 103795, has a listed FDA approval date of Feb 01, 2007. The date is reproduced from this exact Purple Book BLA record and is not a statement about commercial launch or current availability.

Does this page summarize Enbrel's FDA label?

Enbrel, BLA 103795, No exact-BLA label candidate is stored for this record. Approved uses, dosing, and warnings are intentionally unavailable and queued for exact-source research. Therefore the page does not publish product-specific approved uses, dosing, boxed warnings, or safety claims from a reference product or same-ingredient document.

What patent information is published for Enbrel?

Enbrel, BLA 103795, has no published patent rows in the loaded Purple Book patent data. That is a bounded source result, not proof that no relevant patent rights exist or a freedom-to-operate conclusion.

What exclusivity information is listed for Enbrel?

Enbrel, BLA 103795, has 1 populated Purple Book exclusivity field, with the latest listed date on May 27, 2006. Regulatory exclusivity dates are not patent opinions, inventory signals, or guaranteed market-entry dates.

FDA Purple Book product · 351(a) biologic

Enbrel

etanercept

Enbrel, BLA 103795, is listed in the FDA Purple Book as a 351(a) reference biologic. This page consolidates 6 exact FDA presentation rows, and 3 FDA rows name-link 351(k) follow-on products to its reference family. It separates the BLA applicant from any unverified manufacturer and does not infer clinical labeling, pharmacy substitution, commercial availability, or patent conclusions.

351(a)BLA 103795 6 presentationsRxLicensed Immunex Corporation

Approved

Feb 01, 2007

License type

351(a)

Marketing

Listed patents

Enbrel (etanercept) is Immunex Corporation's FDA-licensed 351(a) biologic under BLA 103795, approved in 2007. 3 distinct approved follow-on biologics explicitly reference Enbrel (Erelzi, Erelzi Sensoready, and Eticovo), making its reference-product role visible in the loaded family data.

Sourced from the FDA Purple Book · verified Aug 11, 2026

What this Purple Book record establishes

Regulatory interpretation

BLA number

103795

Regulatory role

351(a) reference biologic

Applicant

Immunex Corporation

Applicant is not automatically the physical manufacturer.

Presentations

Exact FDA presentation rows under this BLA.

Approval

Feb 01, 2007

Follow-on biologics

Enbrel is a 351(a) reference biologic supported by exact-BLA evidence.

3 distinct licensed follow-on biologics in the loaded Purple Book data name Enbrel as their reference product; exact-BLA patent or exclusivity fields, or an unambiguous single-BLA name match, support this page's role.

Substitution boundary

Substitution status belongs to an individual follow-on product; it cannot be inferred from the reference product alone.

Key dates

Licensure & exclusivity

Orphan exclusivity ends
7-year orphan-drug exclusivity window.
May 27, 2006
20 yr 7 mo ago
Approval
Approval date of this BLA submission.
Feb 01, 2007
19 yr 11 mo ago
Today

Strengths & presentations

6 FDA presentation rows · BLA 103795

Strength

25MG

Dosage form

For Injection

Route

Subcutaneous

Presentation

Single-Dose Vial

Center

CDER

License number

1132

Product number

001

Submission type

Original

Supplement number

Not listed

Change type

Not listed

Exact presentation matrix

One row per FDA presentation under this exact BLA. Missing cells remain unavailable rather than being borrowed from another product.

Exact FDA Purple Book presentation rows for this BLA
Product	Strength	Dosage form	Route	Presentation	Licensure	Marketing
001	25MG	For Injection	Subcutaneous	Single-Dose Vial	Licensed	Disc
002	25MG	For Injection	Subcutaneous	Multi-Dose Vial	Licensed	Rx
003	50MG/ML	Injection	Subcutaneous	Pre-Filled Syringe	Licensed	Rx
004	25MG/0.5ML	Injection	Subcutaneous	Pre-Filled Syringe	Licensed	Rx
006	50MG/ML	Injection	Subcutaneous	Autoinjector	Licensed	Rx
007	25MG/0.5ML	Injection	Subcutaneous	Single-Dose Vial	Licensed	Rx

Other brands under BLA 103795

The rows above are this brand's presentations. FDA also lists the brand below on this BLA, each with its own presentation rows. Strength and reference product come from each brand's own rows; a shared BLA does not establish shared presentations, approved uses, or substitutability.

Enbrel Mini
etanercept · Strength: 50MG/ML

Exact-source evidence coverage

Labeling & approval review

Current product label

Exact-source research required

No exact-BLA label candidate is stored for this record. Approved uses, dosing, and warnings are intentionally unavailable and queued for exact-source research.

FDA approval evidence

Not applicable to 351(a)

A biosimilar totality-of-evidence summary is not applicable to this 351(a) record. Product-specific clinical content still requires an exact-BLA label or review source.

Human review pending

Automated BLA-level interpretation has not been marked human-reviewed. The research queue contains 1 exact-source task. Labeling and approval-review claims stay unavailable until their own match gate passes.

Reference product family

Biosimilars & interchangeables

View full family

3 distinct 351(k) follow-on biologics are linked through FDA-stated reference names to Enbrel; 1 is designated interchangeable and 3 have a licensed status in the loaded snapshot.

Exact-BLA patent, exclusivity, or unambiguous linked-family evidence supports this page's reference role. Name-linked licensed biosimilars and interchangeables are listed below.

Reference-family comparison

Purple Book comparison of products in this reference family
Product	Designation	BLA	Approved	Presentation	Marketing
Enbreletanercept	351(a) reference biologic	103795	Feb 01, 2007	25MG/0.5ML · Subcutaneous	Rx
Erelzietanercept-szzs	351(k) biosimilar	761042	Aug 30, 2016	25MG/0.5ML · Subcutaneous	Disc
Erelzi Sensoreadyetanercept-szzs	351(k) biosimilar	761042	Aug 30, 2016	50MG/ML · Subcutaneous	Disc
Eticovoetanercept-ykro	351(k) interchangeable biosimilar	761066	Apr 25, 2019	50MG/ML · Subcutaneous	Disc

Published patents

BPCIA 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.

Practical characteristics and limits

Source-bounded interpretation

Presentation coverage

6 exact FDA presentation rows are consolidated under this BLA rather than split across duplicate pages.

Administration fields

The loaded rows list Subcutaneous and For Injection and Injection; these are regulatory presentation fields, not dosing instructions.

Applicant boundary

Immunex Corporation is the listed BLA applicant. The page does not relabel the applicant as manufacturer, labeler, distributor, or commercial supplier without an exact product-specific source.

Regulatory comparison

Enbrel is a 351(a) reference biologic supported by exact-BLA evidence. Family comparisons preserve each BLA's own designation and do not use Orange Book therapeutic-equivalence terminology.

Source provenance

FDA Purple Book data

Source kind · Monthly download

Checked Aug 11, 2026

FDA release · June 2026

FDA source FDA source

advanced-searchAdvanced Search · Jul 02, 2026
monthly-downloadMonthly download · Jul 02, 2026

What this record does not establish

Purple Book marketing status is a regulatory field, not real-time commercial inventory or launch status.
The listed applicant or BLA holder is not automatically the product’s physical manufacturer, labeler, or distributor.
Biosimilar status and interchangeability are distinct FDA designations; neither is a therapeutic-equivalence code from the Orange Book.
A missing patent or exclusivity row is not proof that no relevant rights exist, and listed patent information is not a freedom-to-operate opinion.
Approved uses, dosing, warnings, and clinical evidence require the exact current product label or approval package and are not inferred from the reference product.

Change history

Record versions

v5Aug 11, 2026
v4Jul 02, 2026
v3Jul 02, 2026
v2Jul 02, 2026

Enbrel: frequently asked questions

Licensure, biosimilar status, exclusivity, and patents for this biologic, from the FDA Purple Book.

Built directly from the FDA Purple Book database of licensed biological products. License types, approval and exclusivity dates, and the patent list match the official FDA record. The Purple Book patent list reflects the statutory BPCIA patent exchange and is not exhaustive.

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