Byooviz (ranibizumab-nuna)

aBL 761202

Byooviz (ranibizumab-nuna)

aBL 761202

U.S. License Holder:

Samsung Bioepis / Biogen

Date of License:

September-17-2021; October-24-2023 (Interchangeable)

Last Update:

Dec-15-2024

approved_indications FDA-Approved Indications

BYOOVIZ (ranibizumab-nuna), a vascular endothelial growth factor (VEGF) inhibitor, is indicated for the treatment of patients with:

Neovascular (Wet) Age-Related Macular Degeneration (AMD);

Macular Edema Following Retinal Vein Occlusion (RVO);

Myopic Choroidal Neovascularization (mCNV).

approved_indications Approved Foreign Follow-On Biologics / Biosimilars

Biosimilars Approved In Canada

Byooviz (Samsung Bioepis / Biogen) (March-2022)

Biosimilars Approved In The E.U.

Byooviz (Samsung Bioepis / Biogen) (August-2021)

Biosimilars Approved In Australia

Byooviz (Samsung Bioepis) (August-2022)

Biosimilars Approved In South Korea

Amelivu (Samsung Bioepis) (May-2022)

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Methodology

Information contained in the Venable BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website (www.fda.gov). Information relating to FDA licensed products, FDA-approved indications, and aBLA and 505(b)(2) applications is obtained from public sources including the U.S. FDA website (www.fda.gov). Information relating to litigations is given only for cases active from January 31, 2010 onward. Information relating to foreign biosimilar / biologics follow-on products approved in Australia, Canada, the E.U., Japan and South Korea is from public sources. Statistics graphics are compiled from information contained in the Venable BiologicsHQ database.

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