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FDA Purple Book product · 351(a) biologic

Susvimo

ranibizumab

Susvimo, BLA 761197, is listed in the FDA Purple Book as a 351(a) reference biologic. This page consolidates 1 exact FDA presentation row, and 3 FDA rows name-link 351(k) follow-on products to its reference family. It separates the BLA applicant from any unverified manufacturer and does not infer clinical labeling, pharmacy substitution, commercial availability, or patent conclusions.

351(a)BLA 761197RxLicensed Genentech, Inc.
Approved
Oct 22, 2021
License type
351(a)
Marketing
Rx
Listed patents
11
Susvimo (ranibizumab) is Genentech, Inc.'s FDA-licensed 351(a) biologic under BLA 761197, approved in 2021. The FDA Purple Book lists 11 published patents for it, the last expiring 2035. 3 distinct approved follow-on biologics explicitly reference Susvimo (Byooviz, Cimerli, and Nufymco), making its reference-product role visible in the loaded family data.

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

What this Purple Book record establishes

Regulatory interpretation

BLA number

761197

Regulatory role

351(a) reference biologic

Applicant

Genentech, Inc.

Applicant is not automatically the physical manufacturer.

Presentations

1

Exact FDA presentation rows under this BLA.

Approval

Oct 22, 2021

Follow-on biologics

3

Susvimo is a 351(a) reference biologic supported by exact-BLA evidence.

3 distinct licensed follow-on biologics in the loaded Purple Book data name Susvimo as their reference product; exact-BLA patent or exclusivity fields, or an unambiguous single-BLA name match, support this page's role.

Substitution boundary

Substitution status belongs to an individual follow-on product; it cannot be inferred from the reference product alone.

Key dates

Licensure & exclusivity

  1. Approval

    Approval date of this BLA submission.

    Oct 22, 2021

    5 yr ago

  2. Today

Pharmaceutical detail

FDA product record

Strength

100MG/ML

Dosage form

Injection

Route

Intravitreal

Presentation

Single-Dose Vial

Center

CDER

License number

1048

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
001100MG/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

Not applicable to 351(a)

A biosimilar totality-of-evidence summary is not applicable to this 351(a) record. Product-specific clinical content still requires an exact-BLA label or review source.

Human review pending

Automated BLA-level interpretation has not been marked human-reviewed. The research queue contains 1 exact-source task. Labeling and approval-review claims stay unavailable until their own match gate passes.

Reference product family

Biosimilars & interchangeables
View full family

3 distinct 351(k) follow-on biologics are linked through FDA-stated reference names to Susvimo; 3 are designated interchangeable and 3 have a licensed status in the loaded snapshot.

Exact-BLA patent, exclusivity, or unambiguous linked-family evidence supports this page's reference role. Name-linked licensed biosimilars and interchangeables are listed below.

Reference-family comparison

Purple Book comparison of products in this reference family
ProductDesignationBLAApprovedPresentationMarketing
Susvimoranibizumab351(a) reference biologic761197Oct 22, 2021100MG/ML · IntravitrealRx
Byoovizranibizumab-nuna351(k) interchangeable biosimilar761202Sep 17, 202110MG/ML · IntravitrealRx
Cimerliranibizumab-eqrn351(k) interchangeable biosimilar761165Aug 02, 202210MG/ML (0.5MG/0.05ML) · IntravitrealRx
Nufymcoranibizumab-leyk351(k) interchangeable biosimilar761473Dec 18, 202510MG/ML (0.5MG/0.05ML) · 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

Genentech, Inc. 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

Susvimo is a 351(a) reference biologic supported by exact-BLA evidence. 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

Susvimo: 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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