The Economic Times

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.