Samsung Bioepis' 'Afilibu', Korea's First Ilyea Biosimilar Approved

Samsung Bioepis has received approval for Apilibu (development code SB15), a biosimilar of the ophthalmic disease treatment drug Eylea, marking the first approval among biosimilars of the same product.

Exterior view of Samsung Bioepis building in Songdo, Incheon [Photo by Samsung Bioepis]

Eylea is an ophthalmic disease treatment drug developed by Regeneron in the United States for conditions such as wet age-related macular degeneration. Macular degeneration is considered a representative cause of blindness. Blood and other fluids leaking from abnormally grown capillaries in the macula, the central part of the retina, adhere to the retina and obscure vision. Therefore, treatments like Eylea, which inhibit new blood vessel formation, or antibody therapies with similar mechanisms such as Lucentis, must be administered regularly to suppress disease progression.

Since aging is a major cause, the incidence is increasing significantly worldwide along with population aging. Global market research firm GlobalData forecasts that the market for macular degeneration treatments in the seven major countries (G7) including the United States, France, and Germany will grow from $7.4 billion in 2021 to $27.5 billion (approximately 37 trillion KRW) by 2031. Eylea is also considered a global blockbuster, having recorded sales of $9.3806 billion (approximately 12.5 trillion KRW) last year.

Samsung Bioepis previously obtained marketing approval for Amelibu (SB11), a biosimilar of Lucentis, in 2022, and now Apilibu has become the first approved biosimilar of Eylea. With this, Samsung Bioepis has increased the total number of biosimilar products approved domestically to eight, and the number of ophthalmic disease biosimilars to two. Samsung Bioepis plans to sell Apilibu through Samil Pharmaceutical, the domestic sales partner for Amelibu.

Jung Byung-in, Head of Regulatory Affairs (RA) Team at Samsung Bioepis (Executive Director), said, “Through the approval of Apilibu, we have once again demonstrated Samsung Bioepis’s capabilities in biopharmaceutical research and development. We will continue to strive to contribute to addressing unmet medical needs in the domestic ophthalmic disease field.”

This content was produced with the assistance of AI translation services.