US FDA Accepts Biologics License Application (BLA) For HLX11, Biosimilar Candidate Of Perjeta (pertuzumab)
Shanghai Henlius Biotech, Inc. announced that the US Food and Drug Administration (FDA) has accepted the Biologic License Application (BLA) for HLX11, an investigational biosimilar of Perjeta (pertuzumab).
Perjeta has been approved in various countries and regions in combination with trastuzumab and chemotherapy for the neoadjuvant treatment of patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer, and adjuvant treatment for certain HER2-positive early breast cancer, among other indications.
In 2022, Henlius entered into a license and supply agreement with Organon, granting Organon and its affiliates the exclusive global commercialization rights to two biosimilar candidates, including HLX11. The agreement covers markets such as the United States, the European Union, and Canada. An exception to the agreement is China.
The filing is based on data from a series of studies for HLX11 versus Perjeta, including analytical similarity studies and two comparative clinical studies. The first of the clinical studies was a randomized, double-blind, single-dose, parallel-controlled, four-arm phase 1 study aimed to compare the pharmacokinetics, safety and immunogenicity of HLX11 with US-, EU- and China-sourced pertuzumab administrated intravenously in healthy Chinese male subjects. The second was a multicenter, randomized, double-blind, parallel-controlled phase 3 clinical study comparing the efficacy and safety of HLX11 with EU-sourced reference pertuzumab as a neoadjuvant therapy in patients with HER2-positive, HR-negative early, or locally advanced breast cancer. Previously, the new drug application for HLX11 was accepted by China’s National Medical Products Administration (NMPA).
Source: Shanghai Henlius Biotech, Inc.