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Amgen Initiates Ph 3 Study for Pembrolizumab Biosimilar

May 2, 2024

On 2 May 2024, Amgen revealed that it initiated a Phase 3 study to compare the efficacy, pharmacokinetics, safety and immunogenicity of its pembrolizumab biosimilar, ABP 234, with Keytruda® in patients with advanced or metastatic non-squamous non-small cell lung cancer.

In April 2024, Samsung Bioepis announced commencement of Ph 3 clinical trials for its pembrolizumab biosimilar, SB27, and in March 2024, Korea Biomedical Review reported that  Rophibio entered into an agreement with US biotech Avantor  in relation to the development of a pembrolizumab biosimilar.  Formycon, Xbrane, and Celltrion have each previously announced their development of pembrolizumab biosimilars.