Shots:
- Samsung Bioepis has reported the P-I & P-III trial results on SB27, a proposed biosimilar to Keytruda (pembrolizumab), which met their 1EP, with trial completion expected within 2026
- The P-I trial (n=163) evaluated PK, efficacy, safety, & immunogenicity of SB27 vs EU & US-sourced Keytruda in resected stage II/IIIA NSCLC pts after adjuvant Pt-based CT, which demonstrated PK bioequivalence
- The P-III trial evaluated efficacy, safety, PK, & immunogenicity of SB27 vs Keytruda, both with pemetrexed & carboplatin, in 555 pts with metastatic non-squamous NSCLC, demonstrating equivalent ORR at Wk. 24 & comparable safety, PK, & immunogenicity
Ref: Businesswire | Image: Samsung Bioepis | Press Release
Related News: Samsung Bioepis & Organon Expand Deal to Commercialize Pyzchiva (Biosimilar, Stelara) in Canada
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