On 1 September 2026, AstraZeneca announced that Enhertu® (trastuzumab deruxtecan), developed in conjunction with Daiichi Sankyo, in combination with Roche/Genentech’s Perjeta® (pertuzumab) has been approved by the European Commission for the first-line treatment of adult patients with unresectable or metastatic HER2-positive breast cancer.
This is reported to be the first new regimen in more than a decade to be approved in the EU for the first line treatment of this disease and follows a CHMP recommendation in July 2026. The Enhertu®/Perjeta® combination was approved by the FDA for the same indication in December 2025, as the first new, first-line treatment of metastatic HER2-positive breast cancer approved in a decade in the US.
Biosimilars of each of trastuzumab deruxtecan and pertuzumab are under development. Samsung Bioepis has a trastuzumab deruxtecan biosimilar in its pipeline, while Shanghai Henlius and Organon are leading the pertuzumab biosimilar race in major markets, with approvals of Poherdy® (pertuzumab) secured in the US (November 2025), EU (April 2026), and China (as Hanbeiyou®, May 2026). Roche/Genentech are currently suing Biocon in the US in relation to biosimilar pertuzumab (Bmab 1500).
Approvals for pertuzumab biosimilars have been granted in India for Intas’ product (December 2024), Zydus’ Sigrima™ (June 2024, subject to ongoing litigation) and Enzene’s Pertuza®/Perzea® (launched September 2025). In Russia, Biocad’s Pertuvia™ (May 2025, subject to litigation) and R-Pharm’s Persinthia™ (February 2026) are approved.
Intas obtained Indian approval in November 2025 for a phase 1 trial comparing a combination of pertuzumab and trastuzumab with the reference product, Roche’s Phesgo®.