FDA Approves Samsung Bioepis and Biogen’s Lucentis Biosimilar

On September 20th , Byooviz, a Lucentis biosimilar developed by Samsung Bioepis and Biogen, won FDA approval, making it the first ophthalmology biosimilar to be approved by the FDA. 

Byooviz (ranibizumab-nuna) references Roche’s blockbuster drug Lucentis. The alternative option to Lucentis is approved as treatment for three eye disorders: the “wet” form of neovascular age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO), and myopic choroidal neovascularization (mCNV).

Roche’s Blockbuster Drug Lucentis

Lucentis is an antibody drug that blocks vascular endothelial growth factor (VEGF), a protein promoting abnormal growth of blood vessels in several eye diseases. By monthly injection, Lucentis blocks the abnormal pathway in the eyes, allowing them to function normally.

In 2020, Roche’s Lucentis generated more than $1.6 billion in sales, down from $1.8 billion in 2019. The decline will become more pronounced as rivals pop out from the biosimilars market.

Two Companies’ Ophthalmology Biosimilar Collaboration 

The FDA approval is based on a Phase 3 efficacy and safety study published this January, which enrolled 705 participants over 52 weeks. The results showed that Byooviz demonstrated equivalent safety and efficacy to Roche’s Lucentis, while the immunogenicity was also comparable. Byooviz may launch in the U.S. market starting from June 2022.

The collaboration between Samsung Bioepis and Biogen can be traced back to November 2019, when two companies partnered to develop two ophthalmology biosimilar candidates. Besides Byooviz, another biosimilar drug SB15 references Regeneron Pharmaceuticals’ Eylea. Samsung Bioepis launched a Phase 3 clinical trial for SB15 in late June.

Author

Kathy Huang

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