Celltrion Inc., of Incheon, South Korea, said the EMA's Committee for Medicinal Products for Human Use issued a positive opinion recommending that Herzuma (trastuzumab biosimilar) be granted marketing authorization in the European Union for the treatment of patients with early breast cancer, metastatic breast cancer or metastatic gastric cancer whose tumors have either HER2 overexpression or HER2 gene amplification. A BLA is under review for Herzuma in the U.S.