In a significant development that can be termed as a precursor for biosimilar launch in the US, the USFDA Oncologic Drugs Advisory Committee (ODAC) has strongly recommended approval of Biocon/Mylan's proposed biosimilar Trastuzumab, a biologically similar version of Roche's breast-cancer drug Herceptin. Herceptin is indicated to treat certain HER2-positive breast and gastric cancers. The committee voted 16-0 in support of eligible indications of the reference product. During the discussion, ODAC determined that no clinically meaningful...