Sandoz, a Novartis division, announced that the Committee for Medicinal Products for Human Use, or CHMP, of the European Medicines Agency has adopted a positive opinion recommending marketing authorization for their biosimilar trastuzumab, developed by EirGenix, Inc. The positive opinion for Sandoz trastuzumab, a monoclonal antibody, covers treatment of human epidermal growth factor receptor 2 positive breast cancer and metastatic gastric cancers, the same indications as approved by EMA for the reference biologic.
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