Purple Book product · Reference 351(a)

Semglee

insulin glargine

351(a)BLA 210605DiscVoluntarily Revoked Mylan Pharmaceuticals Inc.

View insulin glargine family Label PDF Open on FDA Purple Book

Jun 11, 2020

Approved

Reference 351(a)

License type

Disc

Marketing

None

Listed patents

Semglee (insulin glargine) is Mylan Pharmaceuticals Inc.'s FDA-licensed reference biologic, approved under a 351(a) BLA in 2020. 3 approved follow-on biologics reference Semglee (Semglee, Rezvoglar, and Langlara).

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

Key dates

Approval
Approval date of this BLA submission.
Jun 11, 2020
6 yr 2 mo ago
Today

Pharmaceutical detail

Strength

1,000UNITS/10ML (100 UNITS/ML)

Dosage form

Injection

Route

Subcutaneous

Presentation

Multi-Dose Vial

Center

CDER

License number

2210

Product number

001

Submission type

Original

Supplement number

Not listed

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 Semglee have approved biosimilars?

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

What is Semglee's BLA number?

Semglee is licensed under BLA 210605, held by Mylan Pharmaceuticals Inc..

When was Semglee approved by the FDA?

Semglee was approved by the FDA on Jun 11, 2020.

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