Sandoz: CHMP Adopts Positive Opinion For Biosimilar Trastuzumab

(RTTNews) - Sandoz announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion recommending marketing authorization for their biosimilar trastuzumab, developed by EirGenix, Inc. The compay noted that the positive opinion covers treatment of HER2-positive breast cancer and metastatic gastric cancers, the same indications as approved by EMA for the reference biologic.

Sandoz and EirGenix signed a license agreement in April 2019, under which EirGenix will remain responsible for the development and manufacturing of trastuzumab, while Sandoz will hold the rights to commercialize the medicine upon approval in respective markets.

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