Samsung Bioepis Selects Samil Pharmaceutical as Domestic Partner for Ophthalmic Biosimilar

Samsung Bioepis and Samil Pharmaceutical announced on the 1st that they have signed a marketing partnership agreement for the domestic sales of 'SB15,' a biosimilar developed for the ophthalmic disease treatment drug 'Eylea' (active ingredient Aflibercept).

Incheon Songdo Samsung Bioepis Building
[Photo by Samsung Bioepis]

Eylea is an ophthalmic disease treatment drug developed by Regeneron for conditions such as macular degeneration. It is a blockbuster drug that recorded global sales of $9.6474 billion (approximately 12 trillion KRW) in 2022. It works by binding to vascular endothelial growth factor (VEGF) to inhibit the formation of new blood vessels. Macular degeneration is a disease that causes vision impairment due to aging, inflammation, and other factors affecting the macula, the central nerve tissue of the retina. It is also an age-related disease and is considered one of the 'three major causes of blindness' along with glaucoma and diabetic retinopathy.

Samsung Bioepis conducted a global Phase 3 clinical trial of SB15 from June 2020 to March 2022 involving 449 patients with neovascular age-related macular degeneration (nAMD) in 10 countries including the United States and South Korea. In April last year, the clinical equivalence in efficacy and safety with the original drug was confirmed and the results were presented at the annual meeting of the Association for Research in Vision and Ophthalmology (ARVO) in the United States. However, the product has not yet been approved domestically. Approval procedures are currently underway in major countries including South Korea, the United States, and Europe.

Samsung Bioepis and Samil Pharmaceutical have previously collaborated for the sales of 'Amelibu,' another biosimilar for macular degeneration treatment. Amelibu is a biosimilar of Genentech's macular degeneration treatment drug 'Lucentis.' They signed a partnership agreement in June 2022 and have been selling it domestically since January last year. Amelibu is marketed overseas under the product name 'Byooviz.'

Samsung Bioepis collaborates with Samil Pharmaceutical to sell the biosimilar of the macular degeneration treatment 'Lucentis,' named 'Amelibu,' in South Korea.
[Photo by Samil Pharmaceutical]

Go Han-seung, CEO of Samsung Bioepis, said, “Through this agreement, we have been able to further enhance the synergy between our research and development capabilities and Samil Pharmaceutical’s sales and marketing expertise. We will strive to provide treatment opportunities through high-quality biopharmaceuticals to more patients with ophthalmic diseases in Korea.”

Heo Seung-beom, Chairman of Samil Pharmaceutical, said, “Based on the trust built through cooperation on Amelibu, the signing of the domestic distribution and sales contract for SB15 has expanded treatment options in the retinal disease area. We expect to fully utilize Samil Pharmaceutical’s strengths in the ophthalmic disease market to actively promote the efficacy and safety of SB15 based on scientific evidence, benefiting patients with retinal diseases.”

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