On February 2, 2025, Shanghai Henlius Biotech, Inc. (“Henlius”) announced FDA acceptance of the Biologics License Application (BLA) for HLX11, a proposed biosimilar to Genentech’s PERJETA. This marks the first U.S. BLA acceptance for a pertuzumab biosimilar, a targeted therapy for select patients with HER2-positive breast cancer.
Pertuzumab is currently indicated by the FDA for use in combination with: 1) trastuzumab (HERCEPTIN) and docetaxel for treatment of patients with HER2-positive metastatic breast cancer who have not received prior anti-HER2 therapy or chemotherapy; and 2) trastuzumab and chemotherapy as the neoadjuvant treatment of patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer.
The BLA for HLX11 is supported by data from a series of studies for HLX11 versus PERJETA, including analytical similarity studies and two comparative clinical studies. The first, a phase 1 study, aimed to compare the pharmacokinetics, safety, and immunogenicity of HLX11 with US-, EU- and China-sourced pertuzumab administrated intravenously in healthy male adults in China. The second, a phase 3 clinical study, compared the efficacy and safety of HLX11 with EU-sourced pertuzumab as a neoadjuvant therapy in patients with HER2-positive, HR-negative early, or locally advanced breast cancer.
In 2022, Henlius granted Organon LLC exclusive global commercialization rights for HLX11 in the United States, the European Union, and Canada. China’s National Medical Products Administration (NMPA) previously accepted the new drug application (NDA) for HLX11 on December 4, 2024.
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