China-based Henlius Biotech has received US regulatory approval for Poherdy (pertuzumab), marking the first interchangeable biosimilar for the HER2-targeted monoclonal antibody (mAb) used in breast cancer. The nod enables pharmacy-level substitution without prescriber intervention for reference product Perjeta, originally developed by Genentech, with USD 4.03 billion global sales in 2024 across metastatic neoadjuvant and adjuvant settings in combination with trastuzumab and chemotherapy.

Poherdy demonstrated high similarity to reference product in analytical and clinical studies, supporting approval for all licensed indications including HER2-positive metastatic breast cancer and early-stage disease with high recurrence risk. Henlius continues expanding its oncology biosimilar portfolio, including trastuzumab and bevacizumab analogues, while advancing its innovative pipeline in immuno-oncology and autoimmune diseases through internal development and partnership models.

PharmCube's NextBiopharm® database lists two other developers of approved pertuzumab biosimilars, namely Qilu and Chia Tai Tianqing, whose products are registered in their China homeland. Click here to request a free trial for NextBiopharm®.