Samsung EPIS Holdings Subsidiary Samsung Bioepis Seeks FDA Approval for Keytruda Biosimilar

Bitget2026/10/30 08:18

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Samsung Bioepis, a Samsung EPIS Holdings subsidiary, filed for FDA approval of Keytruda biosimilar SB27 on Oct. 29, 2026.
In a 555-patient Phase 3 trial, the 24-week response-rate ratio's 90% confidence interval fell within predefined equivalence limits.
Treatment-emergent adverse event rates, including serious events, were similar between SB27 and Keytruda.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Samsung EPIS Holdings Co. Ltd. published the original content used to generate this news brief via DART, the regulatory disclosure system operated by the South Korea Financial Supervisory Service (FSS) (Ref. ID: 20261030801097), on October 30, 2026, and is solely responsible for the information contained therein.

Disclaimer: The content of this article solely reflects the author's opinion and does not represent the platform in any capacity. This article is not intended to serve as a reference for making investment decisions.

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Samsung EPIS Holdings Subsidiary Samsung Bioepis Seeks FDA Approval for Keytruda Biosimilar

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