Zydus moves closer to US market for Keytruda biosimilar as FDA accepts application

Zydus Lifesciences has received acceptance for its application regarding the biosimilar of Keytruda, which is a major cancer drug. The USFDA is expected to complete its review process by the third quarter of 2027. This biosimilar, named FYB206, was developed without a comparative Phase III efficacy trial. Zydus aims to make effective treatments more accessible in the oncology field in North America.