Novartis: positive opinion for trastuzumab biosimilar

(CercleFinance.com) - Sandoz, Novartis' generics subsidiary, today announced that the CHMP expert committee of the European Medicines Agency (EMA) has issued a positive opinion on its marketing authorisation application for a biosimilar of trastuzumab, an anti-cancer drug produced by the Taiwanese company EirGenix.


The CHMP recommended approval of the molecule, a monoclonal antibody originally discovered by Roche and marketed under the trade name Herceptin, for the same indications as trastuzumab, namely HER2-positive breast cancer and metastatic gastric cancer.

For the record, Sandoz and EirGenix signed a licensing agreement in 2019 under which EirGenix would remain responsible for manufacturing trastuzumab, while Sandoz would be responsible for marketing it.

Note that Novartis' shareholders approved the proposed demerger of Sandoz on Friday, with a separation expected to take place on, or around 4 October, via the distribution of a dividend in kind in the form of Sandoz shares.


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