Samsung Bioepis Initiates Global Clinical Trials for Ophthalmic Disease Treatment 'SB15'

[Asia Economy Reporter Cho Hyun-ui] Samsung Bioepis announced on the 1st that it has commenced the global Phase 3 clinical trial of SB15 (Eylea biosimilar), a treatment for ophthalmic diseases.

According to Samsung Bioepis, the company recently finalized the Phase 3 clinical trial plan for SB15 and disclosed it on the global clinical trial information website, ClinicalTrials.

Samsung Bioepis plans to conduct a comparative study on the efficacy, safety, pharmacokinetics, and immunogenicity between SB15 and the original drug in 446 patients with exudative (characterized by the leakage of blood components outside blood vessels due to inflammation) age-related macular degeneration across 10 countries, including South Korea and the United States, until February 2022.

Eylea is a blockbuster ophthalmic disease treatment developed by Regeneron in the United States, indicated for macular degeneration and diabetic macular edema. Its global sales reached $7.5416 billion (approximately 8.7 trillion KRW) last year.

A Samsung Bioepis official stated, "Through the successful development of SB15, we will secure a diverse product portfolio and strive to expand patients' access to high-quality biopharmaceutical treatments."