On 15 December 2025, AstraZeneca announced that the FDA has approved the combination of Enhertu® (trastuzumab deruxtecan) with Roche’s Perjeta® (pertuzumab) for the 1st-line treatment of adult patients with unresectable or metastatic HER2-positive breast cancer. This is the first new 1st-line treatment approved in a decade for this indication.
Enhertu® has previously been approved as monotherapy for breast cancer including in Australia (October 2021), Japan (March 2023), China (July 2023), New Zealand (December 2023), USA (January 2025) and India (May 2025). A biosimilar to Enhertu® is reportedly under development by Samsung Bioepis.
Roche has been fighting a rising tide of pertuzumab biosimilars including in the USA and India with other competitors on the horizon in China, Europe and Russia.