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Approval Alert: EC Approves Sandoz’s & EirGenix’s Herwenda® (trastuzumab)

Nov 17, 2023

EirGenix announced that Herwenda®, Eirgenix and Sandoz’s biosimilar to Genentech’s Herceptin® (trastuzumab), received approval from the European Commission for the same indications as Herceptin®: HER2-positive breast cancer and metastatic gastric cancers.  On 30 April 2019, Sandoz and EirGenix inked a deal under which EirGenix develops & makes Herwenda®, and Sandoz commercialises the biosimilar on approval for all regions other than Taiwan, China, Russia, and some Asian countries.

On 15 September 2023, EMA’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Herwenda®.