US FDA approves Samsung Bioepis and Biogen’s Byooviz

The US Food and Drug Administration (FDA) has approved Samsung Bioepis and Biogen’s Byooviz (ranibizumab-nuna), a biosimilar referencing Lucentis (ranibizumab).

Byooviz is an anti-vascular endothelial growth factor (VEGF) treatment that can prevent the loss of eyesight in people suffering with retinal vascular disorders that can lead to irreversible blindness or visual impairments in adults.

This is indicated for the treatment of neovascular (wet) age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO), and myopic choroidal neovascularization (mCNV).

Developed by Samsung Bioepis, the drug is claimed to be the first ophthalmology biosimilar to receive approval in the US.

It has already been approved in Europe, including 27 European Union (EU) member countries, and in the UK last month.

The FDA approval is based on a totality of data that includes analytical, non-clinical and clinical data.

In November last year, the FDA accepted the companies’ biologics licence application for SB11, a proposed biosimilar referencing Lucentis

Biosimilars are biological products that are said to be similar in efficacy and safety to the originator’s reference product and provide cost savings and boost sustainable access to treatments.

In November 2019, Samsung Bioepis and Biogen signed a commercialisation deal for two ophthalmology biosimilar candidates, SB11 and SB15, which a biosimilar candidate referencing EYLEA (aflibercept).

The company said that Biogen will commercialise SB11 under the brand name Byooviz in the US.

Samsung Bioepis senior vice-president and development division leader Kyung-Ah Kim said: “In the United States, approximately 11 million people are affected with AMD and the prevalence of advanced AMD is growing due to the aging population.

“The approval of the first ranibizumab biosimilar in the US is a monumental milestone for people living with retinal vascular disorders in the US.

“The approval of Byooviz underscores our continued commitment to providing valuable treatment options for people who do not have access to life-enhancing biologic medicines around the world.”

Under the terms of a global license agreement with Genentech, the companies will have the right to market SB11 in the US as of June 2022 before the expiration of Genentech’s applicable SPCs.

Samsung Bioepis and Biogen will also have right to market the drug elsewhere in other territories after the expiration of Genentech’s SPCs.