Samsung Bioepis announced on Friday that it has reached an agreement and licensing contract with Regeneron and Bayer, the original drug manufacturers, for the sale of its ophthalmic treatment SB15 (active ingredient: Aflibercept) in regions outside the United States and Canada, specifically for a low-concentration formulation (40 mg/mL).
This licensing agreement enables Samsung Bioepis to launch SB15 in countries other than the UK, European nations, and South Korea.
SB15 received approval from the European Commission (EC) in 2024 and was introduced in South Korea under the brand name “Afilivu” in May 2024.
Eylea, the original drug on which SB15 is based, is used to treat ophthalmic conditions such as wet age-related macular degeneration. In 2024, Eylea’s global sales reached approximately 14 trillion KRW (approximately 10.5 billion USD).
Linda Choi, Vice President of Samsung Bioepis’ Commercial Division, stated that this agreement marks a significant milestone in improving access to treatment for patients with ophthalmic diseases. It will facilitate the expansion of supply for this biopharmaceutical in European and global markets.