On November 19, Samsung Bioepis announced that the Food and Drug Administration (FDA) had accepted its 351(k) application for its bevacizumab biosimilar SB8. This would be the company’s second biosimilar submission for treating cancer.
Samsung’s trastuzumab biosimilar was approved early in 2019, and it awaits marketing in a crowded market. SB8 would compete with the reference product Avastin® and two approved biosimilars (so far).
The biologic licensing application is supported by a phase 3 clinical trial of the agent in nonsquamous non–small cell lung cancer, in which patients received either the biosimilar or reference product in addition to paclitaxel and carboplatin. The trial resulted in no clinically relevant outcomes differences between patient groups.
If approved, SB8 would be marketed by Merck in the US. An FDA decision is expected in Q4 2020.
