Purple Book product · Reference 351(a)

Toujeo

insulin glargine

351(a)BLA 206538RxLicensed Sanofi-Aventis U.S. LLC

View insulin glargine family Label PDF Open on FDA Purple Book

Mar 26, 2018

Approved

Reference 351(a)

License type

Marketing

None

Listed patents

Toujeo (insulin glargine) is Sanofi-Aventis U.S. LLC's FDA-licensed reference biologic, approved under a 351(a) BLA in 2018. 3 approved follow-on biologics reference Toujeo (Semglee, Rezvoglar, and Langlara).

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

Key dates

Approval
Approval date of this BLA submission.
Mar 26, 2018
8 yr 5 mo ago
Today

Pharmaceutical detail

Strength

900UNITS/3ML (300UNITS/ML)

Dosage form

Injection

Route

Subcutaneous

Presentation

Autoinjector

Center

CDER

License number

1752

Product number

002

Submission type

Supplement

Supplement number

Change type

Not listed

Reference product family

View full family

This is the reference (originator) product. Its approved biosimilars and interchangeables are listed below.

1 additional BLA record for this product (other strengths or presentations) are in the same reference family.

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

Does Toujeo have approved biosimilars?

Yes. 3 approved follow-on biologics reference Toujeo in the Purple Book: Semglee, Rezvoglar, and Langlara.

What is Toujeo's BLA number?

Toujeo is licensed under BLA 206538, held by Sanofi-Aventis U.S. LLC.

When was Toujeo approved by the FDA?

Toujeo was approved by the FDA on Mar 26, 2018.

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