Samil Pharmaceutical is reportedly positioned as a primary candidate for collaboration with Samsung Bioepis in South Korea for the sales of a biosimilar developed for the age-related macular degeneration (AMD) treatment drug ‘Elyea (active ingredient: Aflibercept)’. The recent expiration of South Korean patents on Elyea now enables the production and release of biosimilar products. Industry insiders suggest that an imminent partnership agreement for the sales of Elyea biosimilar 'SB15 (development code)' by Samsung Bioepis is on the horizon later this month. If finalized, this collaboration would grant Samil Pharmaceutical access to crucial AMD treatment drugs, including 'Lucentis (active ingredient: Ranibizumab),' developed by Samsung Bioepis, along with biosimilars of Elyea, all pertinent to neovascular age-related macular degeneration (nAMD).

In March 2022, Samsung Bioepis successfully conducted a global Phase 3 clinical trial, comparing the safety, efficacy, pharmacokinetic characteristics, and immunogenicity of Elyea and SB15 in 449 nAMD patients across 10 countries, demonstrating their equivalence. Currently, the South Korean Ministry of Food and Drug Safety (MFDS) is in the process of reviewing the product approval for SB15, making it challenging to predict the exact release timeline. The ongoing patent lawsuit with Regeneron in the United States also adds uncertainty regarding its impact on the domestic release.

Samil Pharmaceutical is renowned as a pharmaceutical company specializing in the field of ophthalmic diseases such as cataracts and glaucoma. The company's Ophthalmology Business Unit supplies approximately 40 ophthalmic products domestically, recording sales of about $32.8 million in 2022.

The future marketing strategy for Samil Pharmaceutical's biosimilar products for Lucentis and Elyea, targeting similar conditions, will be a key point of observation in the coming months.

Meanwhile, other companies undergoing regulatory reviews after completing global Phase 3 clinical trials in collaboration with Samsung Bioepis include Celltrion and SamChunDang Pharm. Both companies have not disclosed expected approval and release timelines. With the industry anticipating intensified competition in the domestic market for Ilia-related biosimilars, the future developments of these companies are being closely watched.