Samsung Bioepis Begins US Approval Review for Ophthalmic Disease Treatment Drug

[Asia Economy Reporter Cho Hyun-ui] Samsung Bioepis's ophthalmic disease treatment 'SB11' (active ingredient ranibizumab) has entered the U.S. sales approval review stage.

On the 19th, Samsung Bioepis stated, "The preliminary review of the biologic license application for SB11, submitted to the U.S. Food and Drug Administration (FDA) last September, has been completed, and the formal document review has begun."

SB11 is a biosimilar (biologic drug replica) of 'Lucentis,' a macular degeneration treatment marketed by multinational pharmaceutical companies Roche and Novartis. Lucentis's annual global sales amount to approximately 4.6 trillion KRW, with about half of that revenue coming from the U.S. market.

Samsung Bioepis recently announced the final results of the global Phase 3 clinical trial confirming the equivalence between SB11 and Lucentis at the 'American Academy of Ophthalmology' (AAO) annual meeting held virtually.

A Samsung Bioepis representative said, "Through the sales approval review process for SB11, we will demonstrate the company's research and development capabilities and create opportunities to secure a product portfolio in various therapeutic areas."

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