Samsung Bioepis Completes Phase 3 Clinical Trial of Biosimilar 'SB15'

Incheon Songdo Samsung Bioepis New Headquarters Exterior View

[Asia Economy Reporter Chunhee Lee] The global Phase 3 clinical trial of 'SB15' (active ingredient 'Aflibercept'), a biosimilar of the ophthalmic disease treatment drug 'Eylea' developed by Samsung Bioepis, has been completed.

Samsung Bioepis announced on the 31st that it updated the related information on the global clinical trial website 'ClinicalTrials' on the 29th, after the last patient visit for the Phase 3 clinical trial of SB15 was conducted.

Since June 2020, Samsung Bioepis has been conducting a comparative study on the efficacy, safety, pharmacokinetics, and immunogenicity between SB15 and the original drug Eylea in 449 patients aged 50 and over with wet age-related macular degeneration in 10 countries including Korea, the United States, and Japan.

Eylea is an ophthalmic disease treatment drug developed by Regeneron in the United States, indicated for macular degeneration and diabetic macular edema. According to Regeneron, it recorded global sales of $9.3847 billion (approximately 11.3649 trillion KRW) last year.

A Samsung Bioepis official said, “Following SB11, the 'Lucentis' biosimilar approved for sale in the United States and Europe, we will strive to provide treatment opportunities through biosimilars to more patients by developing SB15, the second ophthalmic disease treatment drug.”

Samsung Bioepis plans to announce the results of the data compiled related to the SB15 Phase 3 clinical trial within the second half of this year. After the launch of SB15, Biogen is expected to handle sales in major countries such as the United States and Europe.

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