drugset
Drugs / SB27
last change Sep 2026 re-read 3 minutes ago

SB27

also known as Pembrolizumab
Developed for
non-small cell lung carcinoma
Investigated by
Samsung Bioepis Co., Ltd.

Trials 2

today NCT06348199 · Ph 3 NCT06268613 · Ph 1
202420252026
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 11 trial · 1 met primary
Phase 1 NCT06268613 Jan 2024 → Feb 2026 overdue non-small cell lung carcinoma Samsung Bioepis Co., Ltd. Active not recruiting Met primary
Phase 31 trial · 1 met primary
Phase 3 NCT06348199 Mar 2024 → Mar 2026 overdue non-small cell lung carcinoma Samsung Bioepis Co., Ltd. Active not recruiting Met primary

News releases announcing trial results or a regulatory action · 2

DateIssuerRelease
2026-08-10 Samsung Bioepis Co., Ltd. Regulatory 삼성바이오에피스, 키트루다 바이오시밀러(SB27) 국내 품목허가 신청 samsungbioepis.com ↗
삼성바이오에피스(대표이사 김경아 사장)가 식품의약품안전처에 키트루다 바이오시밀러 후보물질 'SB27'(성분명 펨브롤리주맙)의 품목허가를 신청했다고 10일 밝혔다.
2026-06-29 Samsung Bioepis Co., Ltd. Results 삼성바이오에피스, 키트루다 바이오시밀러(SB27) 임상시험 결과 '동등성 입증' samsungbioepis.com ↗
삼성바이오에피스(대표이사 김경아 사장)가 키트루다 바이오시밀러(성분명 펨브롤리주맙, 프로젝트명 SB27)의 글로벌 임상 1상 및 3상 데이터 분석 결과, 각각의 1차 평가 변수(primary endpoint)에서 동등성을 입증한 것으로 확인했다고 29일 밝혔다.

All press releases naming this drug 4 releases

DateIssuerRelease

Evidence & citations 3 cited values

Every value below carries the sentence it was read from. 2 sources stand behind the page.

FieldValueCited text
Known as SB27 ClinicalTrials.gov intervention name — accepted as the source's own label NCT06268613 ↗
1

NCT06348199 ↗
Known as Pembrolizumab “A Study to Compare the Pharmacokinetics, Efficacy, Safety, and Immunogenicity of Pembrolizumab (SB27, EU Sourced Keytruda, and US Sourced Keytruda) in Subjects With Stage...” NCT06268613 ↗
Route Intravenous “Will be administered intravenously” NCT06268613 ↗