Samsung Bioepis-Biogen’s biosimilar for Lucentis obtains FDA approval

The US Food and Drug Administration (FDA) has approved Samsung Bioepis and Biogen’s Byooviz (ranibizumab-nuna), a biosimilar referencing Lucentis (ranibizumab), to treat neovascular (wet) age-related macular degeneration (AMD).

Developed by Samsung Bioepis, Byooviz is also indicated for use in treating macular oedema following retinal vein occlusion (RVO) and myopic choroidal neovascularization (mCNV).

In November last year, the FDA accepted the companies’ biologics licence application to review the use of SB11 as a biosimilar referencing Lucentis.

Biogen will commercialise SB11 under the brand name Byooviz in the US.

Byooviz is an anti-vascular endothelial growth factor (VEGF) treatment. It can avert vision loss in people with retinal vascular disorders, which can lead to permanent blindness or visual impairments in adults.

The companies noted that Byooviz is the first-ever ophthalmology biosimilar to obtain approval in the US.

The FDA based its approval on a totality of data comprising analytical, non-clinical data and clinical data.

Samsung Bioepis senior vice-president and development division leader Kyung-Ah Kim said: “The approval of the first ranibizumab biosimilar in the US is a monumental milestone for people living with retinal vascular disorders in the US.

21 Sep 2021

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