Zydus Lifesciences (BOM:532321) said Tuesday that it has filed a marketing application with the U.S. and Canadian health authorities for FYB206, the proposed copycat version of the popular cancer therapy, Keytruda, developed in collaboration with German biosimilar firm Formycon.
The company said it expects to hear U.S. Food and Drug Administration's decision on the application in the third quarter next year, but did not provide a timeline for when it would hear back from Health Canada.