Purple Book product · Interchangeable

Semglee

insulin glargine-yfgn

351(k) InterchangeableBLA 761201RxLicensed Biocon Biologics Inc.

View insulin glargine family Label PDF Open on FDA Purple Book

Jul 28, 2021

Approved

Interchangeable

License type

Marketing

None

Listed patents

Semglee (insulin glargine-yfgn) is a Interchangeable referencing insulin glargine, licensed under a 351(k) BLA in 2021 and marketed by Biocon Biologics 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.
Jul 28, 2021
5 yr 1 mo ago
First interchangeable exclusivity ends
Window blocking subsequent interchangeable approvals for the reference product.
Nov 15, 2022
3 yr 9 mo ago
Today

Pharmaceutical detail

Strength

300UNITS/3ML (100UNITS/ML)

Dosage form

Injection

Route

Subcutaneous

Presentation

Autoinjector

Center

CDER

License number

2324

Product number

002

Submission type

Original

Supplement number

Not listed

Change type

Not listed

Reference product family

View full family

Biosimilar of insulin glargine (Lantus)

2 additional BLA records 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

Is Semglee a biosimilar?

Yes. Semglee is a Interchangeable referencing insulin glargine, licensed under a 351(k) BLA.

Is Semglee interchangeable?

Yes. Semglee 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 Semglee's BLA number?

Semglee is licensed under BLA 761201, held by Biocon Biologics Inc..

When was Semglee approved by the FDA?

Semglee was approved by the FDA on Jul 28, 2021.

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