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Samsung Bioepis SB27 Keytruda biosimilar development
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2026-10-30 10:33 UTC → 2026-11-09 02:36 UTC ·
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Samsung Bioepis SB27 Keytruda biosimilar development
Samsung Bioepis has advanced its 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. The application seeks approval for SB27, covering 18 indications, indications including melanoma and melanoma, head and neck cancer, and non-small cell lung cancer. The company has completed Phase 1 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 trials, the latter involving clinical trial. This study involved 555 patients with metastatic non-squamous non-small cell lung cancer across 14 countries, 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 expects overall survival, showed results similar to finish all related clinical trials within the year. This development comes as 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 approach expiration in 2028. the US are set to expire in 2028, additional patents expiring in 2029 may influence the timing of market entry for biosimilars.
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- 2026-11-09 02:36 UTC Samsung Bioepis SB27 Keytruda biosimilar development
- 2026-10-30 10:33 UTC Samsung Bioepis Keytruda biosimilar development
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