Purple Book product · Interchangeable

Bkemv

eculizumab-aeeb

351(k) InterchangeableBLA 761333RxLicensed Amgen Inc.

View eculizumab family Label PDF Open on FDA Purple Book

May 28, 2024

Approved

Interchangeable

License type

Marketing

None

Listed patents

Bkemv (eculizumab-aeeb) is a Interchangeable referencing eculizumab, licensed under a 351(k) BLA in 2024 and marketed by Amgen Inc.. As an interchangeable biosimilar it may be substituted for the reference product at the pharmacy without prescriber involvement, subject to state law.

Sourced from the FDA Purple Book · verified Jul 02, 2026

Key dates

Approval
Approval date of this BLA submission.
May 28, 2024
2 yr 2 mo ago
First interchangeable exclusivity ends
Window blocking subsequent interchangeable approvals for the reference product.
Nov 28, 2025
8 mo ago
Today

Pharmaceutical detail

Strength

300MG/30ML (10MG/ML)

Dosage form

Injection

Route

Intravenous

Presentation

Single-Dose Vial

Center

CDER

License number

1080

Product number

001

Submission type

Original

Supplement number

Not listed

Change type

Not listed

Reference product family

View full family

Biosimilar of eculizumab (Soliris)

SolirisReference 351(a)
eculizumab · Alexion Pharmaceuticals, Inc.
2007

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

Source kind · Advanced Search

Checked Jul 02, 2026

FDA source FDA source

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

Change history

v4Jul 02, 2026
v3Jul 02, 2026
v2Jul 02, 2026

Frequently asked questions

Is Bkemv a biosimilar?

Yes. Bkemv is a Interchangeable referencing eculizumab, licensed under a 351(k) BLA.

Is Bkemv interchangeable?

Yes. Bkemv carries an FDA interchangeability designation, so it may be substituted for the reference product at the pharmacy without prescriber involvement, subject to state law.

What is Bkemv's BLA number?

Bkemv is licensed under BLA 761333, held by Amgen Inc..

When was Bkemv approved by the FDA?

Bkemv was approved by the FDA on May 28, 2024.

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