On 28 July 2026, AstraZeneca announced that India’s Central Drugs Standard Control Organisation (CDSCO) has approved an indication extension for Enhertu® (trastuzumab deruxtecan), followed by taxane, trastuzumab and pertuzumab (THP)), for the neoadjuvant treatment of HER2-positive stage 2 or 3 breast cancer. This follows the conditional approval granted in China in March 2026 for Enhertu® followed by paclitaxel, trastuzumab and pertuzumab (THP) for the same indication.
Enhertu® was approved in India in May 2025 for the treatment of adult patients with unresectable or metastatic HER2-low or HER2-ultralow breast cancer, who have previously received at least one endocrine therapy in metastatic setting.
Enhertu® is the subject of a collaboration between AstraZeneca and Daiichi Sankyo entered in March 2019, under which the companies jointly develop and commercialise trastuzumab deruxtecan globally, except in Japan where Daiichi Sankyo maintains exclusive rights. Daiichi Sankyo is solely responsible for manufacturing and supply.
Samsung Epis announced in January 2026 that Samsung Bioepis is adding a trastuzumab deruxtecan biosimilar to its pipeline, with the product in early stage development in preparation for pre-clinical trials.