Byooviz Purple Book BLA 761202

BLA number: 761202
Proprietary names: Byooviz
Proper names: ranibizumab-nuna
Applicant: Samsung Bioepis Co., Ltd.
Center: CDER
First observed release: 2021-09-01
Latest observed release: 2026-06-01
Newest archive release: 2026-06-01
FDA patent list: No patents listed in the captured FDA patent list; source updated 2025-06-11
Coverage: Present in newest release

Latest Known Product Presentations#

Product, Proprietary name, Proper name table
Product	Proprietary name	Proper name	License type	Strength	Dosage form	Route	Presentation	Marketing	Licensure	Approval	Patent list provided
001	Byooviz	ranibizumab-nuna	351(k) Interchangeable	10MG/ML	Injection	Intravitreal	Single-Dose Vial	Rx	Licensed	2021-09-17

Reference Biological Product#

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
125156	Lucentis	ranibizumab	351(a)	Disc*	2026-06-01

Published Patent List#

No patents for this BLA were listed in the FDA Purple Book patent list captured from the source updated 2025-06-11.

NDC, Proprietary name, Nonproprietary name table
NDC	Proprietary name	Nonproprietary name	Labeler	Source
64406-019	Byooviz	ranibizumab-nuna	BIOGEN INC.	current
82667-018	Byooviz	ranibizumab-nuna	Harrow Eye, LLC	current

Label, Manufacturer, Effective table
Label	Manufacturer	Effective
Byooviz	BIOGEN INC. \| Samsung Bioepis Co., Ltd.	2025-12-01
Byooviz	Harrow Eye, LLC \| Samsung Bioepis Co., Ltd.	2025-11-26

Official Monthly Change Events#

Release, Event, Product table
Release	Event	Product	Name	License type	Status	Applicant
2023-10-01	U	001	Byooviz	351(k) Interchangeable	Rx	Samsung Bioepis Co., Ltd.
2021-09-01	N	001	Byooviz	351(k) Biosimilar	Rx	Samsung Bioepis Co., Ltd.

Observed Product State History#

Release, Product, Name table
Release	Product	Name	License type	Marketing	Licensure	Approval
2023-10-01	001	Byooviz	351(k) Interchangeable	Rx	Licensed	2021-09-17
2021-09-01	001	Byooviz	351(k) Biosimilar	Rx	Licensed	2021-09-17