# Samsung Bioepis SB27 Keytruda biosimilar development > Developing situation record from CLSTR: https://clstr.news/situations/samsung-bioepis-keytruda-biosimilar-development > Updated: 2026-11-08T23:17:21.000Z. Sources: 4. Developments: 3. Samsung Bioepis has advanced the development of SB27, a biosimilar candidate for the immunotherapy drug Keytruda. At the 2026 ESMO annual meeting, the company reported Phase 1 clinical trial results involving 163 non-small cell lung cancer patients, which demonstrated pharmacokinetic equivalence to the original medication. Following these results, Samsung Bioepis submitted a Biologics License Application to the US Food and Drug Administration (FDA) for SB27, covering 18 indications including melanoma, head and neck cancer, and non-small cell lung cancer. The company also applied for product licenses with the South Korean Ministry of Food and Drug Safety in August 2026. At the Society for Immunotherapy of Cancer (SITC) 2026 meeting, the company announced results from its global Phase 3 clinical trial. This study involved 555 patients with metastatic non-squamous non-small cell lung cancer across 14 countries. The trial met its primary endpoint, the objective response rate (ORR) at 24 weeks, confirming clinical equivalence to the original drug. Secondary endpoints, including progression-free survival and overall survival, showed results similar to the original medication. Safety profiles were also comparable, with zero cases of neutralizing antibodies observed. Keytruda, developed by MSD, is a leading PD-1 inhibitor with global annual sales of approximately $31.7 billion. While major substance patents for Keytruda in the US are set to expire in 2028, additional patents expiring in 2029 may influence the timing of market entry for biosimilars. ## Claims - SB27 met the primary endpoint of objective response rate (ORR) at 24 weeks within regulatory equivalence margins. (reported by 3 sources) - The Phase 3 trial included 555 patients with metastatic non-squamous non-small cell lung cancer. (reported by 3 sources) - The trial was conducted across 14 countries. (reported by 3 sources) - Secondary efficacy endpoints including PFS, DOR, and OS were similar to the original drug. (reported by 3 sources) - No neutralizing antibodies (NAb) were observed in the trial. (reported by 3 sources) - Samsung Bioepis applied for product license with the South Korean Ministry of Food and Drug Safety in August. (reported by 3 sources) - Samsung Bioepis applied for product license with the U.S. FDA in October. (reported by 3 sources) ## Timeline ### 2026-11-08: Samsung Bioepis confirms clinical equivalence for Keytruda biosimilar SB27 Samsung Bioepis confirmed that its Keytruda biosimilar, SB27, met primary and secondary endpoints in a global Phase 3 trial, demonstrating clinical equivalence and safety in lung cancer patients. 4 sources. https://clstr.news/cluster/samsung-bioepis-confirms-clinical-equivalence-for-keytruda-biosimilar-sb27 ### 2026-10-30: Samsung Bioepis applies for US FDA approval of Keytruda biosimilar Samsung Bioepis has applied for US FDA approval for SB27, a biosimilar of the blockbuster cancer drug Keytruda, covering 18 indications. 2 sources. https://clstr.news/cluster/samsung-bioepis-applies-for-us-fda-approval-of-keytruda-biosimilar ### 2026-10-26: Samsung Bioepis demonstrates pharmacokinetic equivalence for Keytruda biosimilar Samsung Bioepis has confirmed the pharmacokinetic equivalence, efficacy, and safety of its Keytruda biosimilar candidate, SB27, in Phase 1 clinical trials. 3 sources. https://clstr.news/cluster/samsung-bioepis-demonstrates-pharmacokinetic-equivalence-for-keytruda-biosimilar --- Cite as: Samsung Bioepis SB27 Keytruda biosimilar development. CLSTR, https://clstr.news/situations/samsung-bioepis-keytruda-biosimilar-development