Samsung Bioepis announced on the 30th that it has signed a patent agreement and licensing contract with the original drug developer for the sale of its ophthalmic treatment ‘SB15 (U.S. and European product name: Ophthubiz)’ in regions excluding the U.S. and Canada, allowing for the launch of a low-concentration formulation (40 mg/mL).
According to Samsung Bioepis, SB15 is a biosimilar of 'Aflibercept' (ingredient name: Aflibercept), which was co-developed by Regeneron Pharmaceuticals in the U.S. and Bayer in Germany. Aflibercept is an ophthalmic treatment for indications such as wet age-related macular degeneration and diabetic retinopathy, with global sales expected to reach approximately 14 trillion won by 2024.
Under this agreement, Samsung Bioepis will be able to launch SB15 in the following regions: △United Kingdom (January 2026) △European Union (April 2026) △Other countries excluding South Korea (May 2026). SB15 received approval from the European Medicines Agency (EMA) in 2024 and was approved in South Korea under the product name 'Afilibu', launching in May 2024.
Linda Choi, Vice President of Samsung Bioepis (Head of Commercial Division), stated, “This agreement will be an important opportunity to enhance treatment accessibility for patients with ophthalmic diseases,” and added, “We will continue to strive to make biopharmaceuticals more accessible to healthcare systems, medical professionals, and patients worldwide.”
