Skip to content
Assyro AI
FDA Purple Book product · Biosimilar 351(k)

Garzulys

insulin aspart-fsan

Garzulys, BLA 761497, is listed in the FDA Purple Book as a 351(k) biosimilar. This page consolidates 2 exact FDA presentation rows, and FDA names Novolog as its reference product. It separates the BLA applicant from any unverified manufacturer and does not infer clinical labeling, pharmacy substitution, commercial availability, or patent conclusions.

351(k) BiosimilarBLA 761497 2 presentationsRxLicensed Emerge Bioscience Pte. Ltd.
Approved
Jul 24, 2026
License type
351(k) Biosimilar
Marketing
Rx
Listed patents
0
Garzulys (insulin aspart-fsan) is a Biosimilar 351(k) referencing insulin aspart, licensed under a 351(k) BLA in 2026; the Purple Book lists Emerge Bioscience Pte. Ltd. as the BLA applicant, not necessarily the manufacturer or commercial supplier.

Sourced from the FDA Purple Book · verified Sep 21, 2026

What this Purple Book record establishes

Regulatory interpretation

BLA number

761497

Regulatory role

351(k) biosimilar

Applicant

Emerge Bioscience Pte. Ltd.

Applicant is not automatically the physical manufacturer.

Presentations

2

Exact FDA presentation rows under this BLA.

Approval

Jul 24, 2026

Reference product

Novolog

Garzulys is an FDA-licensed biosimilar without an interchangeability designation in this record.

Garzulys was licensed through the 351(k) pathway as biosimilar to Novolog.

Substitution boundary

Biosimilar status alone is not an FDA interchangeability designation and does not establish automatic pharmacy substitution.

Key dates

Licensure & exclusivity

  1. Approval

    Approval date of this BLA submission.

    Jul 24, 2026

    2 mo ago

  2. Today

Strengths & presentations

2 FDA presentation rows · BLA 761497

Strength

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

Dosage form

Injection

Route

Intravenous, Subcutaneous

Presentation

Multi-Dose Vial

Center

CDER

License number

2395

Product number

001

Submission type

Original

Supplement number

Not listed

Change type

Not listed

Exact presentation matrix

One row per FDA presentation under this exact BLA. Missing cells remain unavailable rather than being borrowed from another product.

Exact FDA Purple Book presentation rows for this BLA
ProductStrengthDosage formRoutePresentationLicensureMarketing
0011,000UNITS/10ML (100UNITS/ML)InjectionIntravenous, SubcutaneousMulti-Dose VialLicensedRx
002300UNITS/3ML (100UNITS/ML)InjectionSubcutaneousAutoinjectorLicensedRx

Exact-source evidence coverage

Labeling & approval review

Current product label

Exact-source research required

No exact-BLA label candidate is stored for this record. Approved uses, dosing, and warnings are intentionally unavailable and queued for exact-source research.

FDA approval evidence

Exact-source research required

No independently matched exact-BLA FDA approval letter or review package is stored, so product-specific biosimilarity or switching evidence is not summarized.

Human review pending

Automated BLA-level interpretation has not been marked human-reviewed. The research queue contains 2 exact-source tasks. Labeling and approval-review claims stay unavailable until their own match gate passes.

Reference product family

Biosimilars & interchangeables
View full family

Garzulys names Novolog as its reference product. The comparison below shows locally matched BLA candidates and follow-ons; it does not invent a reference BLA number when FDA did not state one in the loaded row.

Biosimilar of Novolog

Reference-family comparison

Purple Book comparison of products in this reference family
ProductDesignationBLAApprovedPresentationMarketing
Fiaspinsulin aspart351(a) ambiguous reference candidate208751Sep 29, 20171000UNITS/10ML (100UNITS/ML) · Intravenous, SubcutaneousRx
Novologinsulin aspart351(a) ambiguous reference candidate020986Jun 07, 20001,000UNITS/10ML (100UNITS/ML) · Intravenous, SubcutaneousRx
Garzulysinsulin aspart-fsan351(k) biosimilar761497Jul 24, 2026300UNITS/3ML (100UNITS/ML) · SubcutaneousRx

Published patents

BPCIA 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.

Practical characteristics and limits

Source-bounded interpretation

Presentation coverage

2 exact FDA presentation rows are consolidated under this BLA rather than split across duplicate pages.

Administration fields

The loaded rows list Intravenous, Subcutaneous and Subcutaneous and Injection; these are regulatory presentation fields, not dosing instructions.

Applicant boundary

Emerge Bioscience Pte. Ltd. is the listed BLA applicant. The page does not relabel the applicant as manufacturer, labeler, distributor, or commercial supplier without an exact product-specific source.

Regulatory comparison

Garzulys is an FDA-licensed biosimilar without an interchangeability designation in this record. Family comparisons preserve each BLA's own designation and do not use Orange Book therapeutic-equivalence terminology.

Source provenance

FDA Purple Book data
Source kind · Monthly download
Checked Sep 21, 2026
FDA release · August 2026
FDA source FDA source
  • monthly-downloadMonthly download · Sep 21, 2026

What this record does not establish

  • Purple Book marketing status is a regulatory field, not real-time commercial inventory or launch status.
  • The listed applicant or BLA holder is not automatically the product’s physical manufacturer, labeler, or distributor.
  • Biosimilar status and interchangeability are distinct FDA designations; neither is a therapeutic-equivalence code from the Orange Book.
  • A missing patent or exclusivity row is not proof that no relevant rights exist, and listed patent information is not a freedom-to-operate opinion.
  • Approved uses, dosing, warnings, and clinical evidence require the exact current product label or approval package and are not inferred from the reference product.

Change history

Record versions
  • v1Sep 21, 2026

Garzulys: frequently asked questions

Licensure, biosimilar status, exclusivity, and patents for this biologic, from the FDA Purple Book.

Built directly from the FDA Purple Book database of licensed biological products. License types, approval and exclusivity dates, and the patent list match the official FDA record. The Purple Book patent list reflects the statutory BPCIA patent exchange and is not exhaustive.

Related FDA reference tools

Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.

Book a Demo