Samsung Bioepis reported positive topline results from parallel-run Phase 1 and Phase 3 studies for SB-27, a proposed biosimilar to Merck’s Keytruda (pembrolizumab). The company said preliminary analyses show clinical and pharmacokinetic equivalence to the reference product. The Phase 1/Phase 3 run structure is intended to speed evidence generation while preserving confirmatory comparisons needed for regulatory review. SB-27 adds to the growing slate of immuno-oncology biosimilars preparing for market entry.
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