Samsung Bioepis and Samil Pharmaceutical have announced a marketing partnership for the local sales of SB15, a biosimilar referencing Eylea.

Eylea is a blockbuster ophthalmic drug developed by Regeneron and treats wet age-related macular degeneration (wAMD) and diabetic macular edema (DME), which can lead to vision impairment and, in severe cases, blindness. Eylea is expected to reach substance patent expiration in the U.S. in June 2023 and in Europe in May 2025. The drug had sales of about $9.7 billion worldwide last year.

The collaboration between Samsung Bioepis and Samil Pharmaceutical on SB15 marks their second partnership in the field of ophthalmology.

In June 2022, the two companies had previously agreed on a marketing partnership for Amelivu, a biosimilar referencing Lucentis, which has been available in the Korean market since Jan. 2023.

"Through this agreement, we will further enhance the synergy between our R&D capabilities and Samil Pharmaceutical's sales and marketing expertise," Samsung Bioepis CEO Ko Han-sung said. "We will strive to provide more domestic patients with ophthalmic diseases with treatment opportunities through high-quality biopharmaceuticals."

Samil Pharmaceutical Chairman Huh Seung-bum also said, "The agreement to distribute and sell SB15 in Korea builds on the trust between the two companies through Amelivu's collaboration, further expanding treatment options for retinal diseases."

Samil looks forward to leveraging its strengths in the eye disease market to actively promote the effectiveness and safety of SB15 based on scientific evidence to benefit patients with retinal diseases, Huh added.

Meanwhile, Samsung Bioepis conducted a global phase 3 clinical trial for SB15 in 449 patients with neovascular age-related macular degeneration (nAMD) in 10 countries, including the U.S. and Korea, from June 2020 to March 2022.

In April last year, Samsung Bioepis announced the final results of the phase 3 trial at the annual meeting of the Association for Research in Vision and Ophthalmology (ARVO), confirming the clinical equivalence of the drug's efficacy and safety based on extensive comparative studies with the original drug.