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FDA Purple Book product · Interchangeable

Byooviz

ranibizumab-nuna

Byooviz, BLA 761202, is listed in the FDA Purple Book as a 351(k) interchangeable biosimilar. This page consolidates 1 exact FDA presentation row, and FDA names Lucentis 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) InterchangeableBLA 761202RxLicensed Samsung Bioepis Co., Ltd.
Approved
Sep 17, 2021
License type
351(k) Interchangeable
Marketing
Rx
Listed patents
11
Byooviz (ranibizumab-nuna) is a Interchangeable referencing ranibizumab, licensed under a 351(k) BLA in 2021; the Purple Book lists Samsung Bioepis Co., Ltd. as the BLA applicant, not necessarily the manufacturer or commercial supplier. Its interchangeable biosimilar designation may permit pharmacy-level substitution for the reference product without prescriber intervention, subject to state law; it is not a superiority claim. The Purple Book lists 11 published patents for this product.

Sourced from the FDA Purple Book · verified Aug 11, 2026

What this Purple Book record establishes

Regulatory interpretation

BLA number

761202

Regulatory role

351(k) interchangeable biosimilar

Applicant

Samsung Bioepis Co., Ltd.

Applicant is not automatically the physical manufacturer.

Presentations

1

Exact FDA presentation rows under this BLA.

Approval

Sep 17, 2021

Reference product

Lucentis

Byooviz is an FDA-designated interchangeable biosimilar.

Byooviz is a 351(k) biosimilar of Lucentis and carries an interchangeability designation.

Substitution boundary

An interchangeable designation may permit pharmacy-level substitution for the reference product without prescriber intervention, depending on state pharmacy law; it is not a claim of clinical superiority.

Key dates

Licensure & exclusivity

  1. Approval

    Approval date of this BLA submission.

    Sep 17, 2021

    5 yr 1 mo ago

  2. Today

Pharmaceutical detail

FDA product record

Strength

10MG/ML

Dosage form

Injection

Route

Intravitreal

Presentation

Single-Dose Vial

Center

CDER

License number

2046

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
00110MG/MLInjectionIntravitrealSingle-Dose VialLicensedRx

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

Byooviz names Lucentis 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 Lucentis

Reference-family comparison

Purple Book comparison of products in this reference family
ProductDesignationBLAApprovedPresentationMarketing
Lucentisranibizumab351(a) ambiguous reference candidate125156Jun 30, 200610MG/ML (0.5MG/0.05ML) · IntravitrealDisc*
Susvimoranibizumab351(a) ambiguous reference candidate761197Oct 22, 2021100MG/ML · IntravitrealRx
Byoovizranibizumab-nuna351(k) interchangeable biosimilar761202Sep 17, 202110MG/ML · IntravitrealRx

Published patents

BPCIA patent list
Patents published in the FDA Purple Book Patent List for this product, with expiration date and source link.
PatentExpiresInSource
6,716,602Nov 01, 20214 yr 11 mo agoFDA
6,828,121Jul 08, 20224 yr 3 mo agoFDA
9,688,775Dec 31, 20223 yr 9 mo agoFDA
6,921,659Oct 17, 20233 yr agoFDA
8,383,773Dec 13, 20232 yr 10 mo agoFDA
8,574,869Jul 08, 2028in 1 yr 10 moFDA
10,421,984Sep 19, 2033in 7 yr 1 moFDA
9,765,379Mar 10, 2034in 7 yr 7 moFDA
10,017,732Mar 14, 2034in 7 yr 7 moFDA
10,829,732Mar 14, 2034in 7 yr 7 moFDA
10,112,994Nov 05, 2035in 9 yr 3 moFDA

Practical characteristics and limits

Source-bounded interpretation

Presentation coverage

1 exact FDA presentation row is consolidated under this BLA rather than split across duplicate pages.

Administration fields

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

Applicant boundary

Samsung Bioepis Co., 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

Byooviz is an FDA-designated interchangeable biosimilar. 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 Aug 11, 2026
FDA release · June 2026
FDA source FDA source
  • advanced-searchAdvanced Search · Jul 02, 2026
  • monthly-downloadMonthly download · Jul 02, 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
  • v5Aug 11, 2026
  • v4Jul 02, 2026
  • v3Jul 02, 2026
  • v2Jul 02, 2026

Byooviz: 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.

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