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Samsung Bioepis SB27, Keytruda® (pembrolizumab) Biosimilar Enters the Clinic

Nov 15, 2023

The Korea Herald reported that Samsung Bioepis has received approval from the Ministry of Food and Drug Safety for a phase I clinical trial of SB27, a biosimilar to Merck’s anti-PD-1 therapy Keytruda® (pembrolizumab).  Samsung appears to be ahead of several other companies in its pembrolizumab biosimilar clinical programme, noting that Samsung must commence its trial within a year of the approval.  Formycon, Xbrane and Celltrion previously announced that they have pembrolizumab biosimilars in development.  Formycon reported in its nine-month financial results for 2023 that its pembrolizumab clinical programme will commence in 2024Xbrane reported in its financial reports for Jan-Jun 2023 that its pembrolizumab biosimilar candidate, Xtrudane™, is in preclinical development.  Celltrion has not provided an update on the status of its development.