(CercleFinance.com) – Sandoz, the generic subsidiary of Novartis, announced Monday that the committee of experts (CHMP) of the European Medicines Agency (EMA) had issued a favorable opinion concerning its marketing authorization application. on the market relating to a biosimilar of trastuzumab, an anti-cancer drug produced by the Taiwanese company EirGenix.
The CHMP recommended approval of the molecule, a monoclonal antibody initially discovered by Roche and marketed under the trade name Herceptin, for the same indications as trastuzumab, namely HER2-positive breast cancer and metastatic gastric cancers.
As a reminder, Sandoz and EirGenix entered into a licensing agreement in 2019 whereby EirGenix would remain responsible for the manufacturing of trastuzumab, while Sandoz would be responsible for its marketing.
Note that Novartis shareholders approved the proposed Sandoz split on Friday, with a separation expected to take place on – or around – October 4, via the distribution of a dividend in kind in the form of Sandoz shares.
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