Samsung Bioepis' first in-house drug candidate wins FDA fast track designation

Samsung Bioepis' first in-house anticancer drug candidate has been placed on the US Food and Drug Administration's expedited review track.

The designation is a significant milestone for Samsung Bioepis, which has long led the global biosimilar market. By securing official regulatory support in the high-complexity field of antibody-drug conjugate innovation, the company is signaling a fundamental shift from a pure-play biosimilar maker to a global innovative drug developer.

Samsung Bioepis announced Wednesday that its anticancer drug candidate SBE303 had received fast track designation from the FDA.

SBE303 is an antibody-drug conjugate therapy targeting Nectin-4, a protein overexpressed in tumor cells. It is the company's first proprietary pipeline asset, developed as Samsung Bioepis expands beyond biosimilars into original drug development.

The fast track designation covers the treatment of patients with locally advanced or metastatic urothelial carcinoma who have previously received a Nectin-4-targeting therapy.

The FDA's fast track program is designed to accelerate the development of promising drug candidates that address serious conditions with unmet medical needs where existing treatments have limitations.

Fast track status expands opportunities for direct communication with the FDA during clinical design and the approval process, allowing companies to address regulatory risks proactively from the early stages of development and significantly accelerate the path to commercialization.

"The FDA's fast track designation reflects recognition of SBE303's potential to address unmet needs in the treatment of serious disease," said Jung Byung-in, senior vice president and head of the regulatory affairs team at Samsung Bioepis. "It demonstrates that Samsung Bioepis possesses world-class research and development capabilities in the innovative drug space as well."