Garzulys — licensed biologic

Overview

Source: Purple Book

Proprietary name

Garzulys

Proper name

insulin aspart-fsan

Licence type

351(k) Biosimilar

BLA number

761497

Applicant

Emerge Bioscience Pte. Ltd.

Center

CDER

Presentations

2

First licensure

—

351(k) biosimilar pathway. This product was licensed as highly similar to a reference product, with no clinically meaningful differences in safety, purity or potency. It is licensed as a biosimilar but is not designated interchangeable, so substitution requires the prescriber.

Presentations

Source: Purple Book

Every strength and presentation recorded in the Purple Book for this product.
Strength	Dosage form	Route	Presentation	Status	Licensed
1,000UNITS/10ML (100UNITS/ML)	Injection	Intravenous, Subcutaneous	Multi-Dose Vial	Rx	July 24, 2026
300UNITS/3ML (100UNITS/ML)	Injection	Subcutaneous	Autoinjector	Rx	July 24, 2026

Reference product

Source: Purple Book

This product is licensed with reference to Novolog (insulin aspart).

View reference product Search the small-molecule catalogue

Sources for this page

Purple Book	FDA	Licence type, presentations, reference product, exclusivity