Sandoz Files Marketing Authorization Application To EMA For Biosimilar Trastuzumab

Sandoz, a generic and biosimilar medicines company and an arm of Novartis (NVS), said on Wednesday that it has filed a Marketing Authorization Application for the proposed biosimilar trastuzumab, developed by EirGenix, Inc., to the European Medicines Agency or EMA.

The Swiss company said, the drug biosimilar trastuzumab 150 mg, made for intravenous use, is a monoclonal antibody used for the treatment of breast and metastatic gastric cancers.

As part of the license deal inked in 2019, EirGenix is responsible for the development and manufacturing of the drug, whereas Sandoz has the right to commercialize the medicine upon approval in all markets excluding China and Taiwan.

On December 20, Sandoz said it has submitted biologics license application for the proposed biosimilar trastuzumab 150 mg, to the US Food and Drug Administration (FDA).

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