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[BUSINESS] · South Korea, United States · 4 sources

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Part of situation: Samsung Bioepis SB27 Keytruda biosimilar development (3 clusters)

Samsung Bioepis confirms clinical equivalence for Keytruda biosimilar SB27

Samsung Bioepis SB27 Keytruda biosimilar pembrolizumab clinical trial

Samsung Bioepis announced the results of its global Phase 3 clinical trial for SB27, a biosimilar candidate of the immunotherapy drug Keytruda (pembrolizumab), at the Society for Immunotherapy of Cancer (SITC) 2026 annual meeting in Phoenix, Arizona.

The study involved 555 patients with metastatic non-squamous non-small cell lung cancer across 14 countries. The trial utilized a randomized, double-blind design, comparing SB27 to the original drug in combination with standard chemotherapy. The primary endpoint, the objective response rate (ORR) at 24 weeks, met the predefined regulatory equivalence margins, confirming clinical equivalence to the original medication.

Secondary efficacy endpoints, including progression-free survival (PFS), duration of response (DOR), and overall survival (OS), also showed results similar to the original drug. Regarding safety, the rates of treatment-emergent adverse events (TEAE) and serious adverse events were comparable to the original drug, with zero cases of neutralizing antibodies (NAb) observed.

Samsung Bioepis has already applied for product licenses with the South Korean Ministry of Food and Drug Safety in August and with the U.S. Food and Drug Administration in October.

Entities

Merck (MSD) · Phoenix, Arizona · SITC 2026 · Samsung Bioepis · U.S. Food and Drug Administration

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Sources

삼바에피스 ‘키트루다 시밀러’ 임상 3상 동등성·안전성 확인 [biz.heraldcorp.com]
삼성바이오에피스, 키트루다 시밀러 3상 중간분석서 동등성 확인 - 코메디닷컴 [kormedi.com]
삼성바이오에피스, 키트루다 바이오시밀러 임상 3상 동등성 확인 - 바이오타임즈 [www.biotimes.co.kr]
삼성바이오에피스, SITC 2026서 키트루다 시밀러 ‘SB27’ 3상 동등성 확인 [www.thebionews.net]