Organon and Shanghai Henlius Biotech have announced that the European Medicines Agency (EMA) has validated a marketing authorisation application for HLX11, a biosimilar candidate referencing Roche’s Perjeta (pertuzumab).
Perjeta holds approvals for multiple HER2-positive breast cancer indications, including in combination with trastuzumab and chemotherapy for the neoadjuvant treatment of patients with HER2-positive, locally advanced, inflammatory or early-stage breast cancer.
Breast cancer is the second most common cancer worldwide, with 2.3 million cases of the disease diagnosed in women in 2022 alone. HER2-positive breast cancer tends to be more aggressive than other types of the disease, but often responds well to therapies that specifically target the HER2 protein.
Pertuzumab is designed to attach to HER2 and stop it from producing signals that cause the cancer cells to grow. It also activates cells of the immune system, which then kill the cancer cells.
A biosimilar, according to the EMA, is a biological medicine that is highly similar to one already approved in the EU. This means patients can expect the same safety and effectiveness from the biosimilar as they would from the reference product.
The submission for HLX11 is supported by positive results from a phase 3 trial comparing the efficacy and safety of the investigational biosimilar with reference Perjeta as a neoadjuvant therapy in patients with HER2-positive, HR-negative early-stage, or locally advanced breast cancer as part of a complete treatment regimen.
The study met its primary endpoint of pathological complete response, and other secondary endpoint indicators were also shown to be comparable between the two treatment cohorts, the partners said.
Organon gained exclusive commercialisation rights to HLX11 in 2022, when it entered into a license and supply agreement with Henlius. The deal, which also includes a biosimilar referencing Amgen’s bone disease therapy denosumab, covers markets such as the EU, US and Canada, but not China.
“With our experience in biosimilars and women’s health, our goal is to help more patients gain access to treatments for breast cancer and osteoporosis, two areas that significantly impact the health of women,” said Kevin Ali, Organon’s chief executive officer, at the time of the announcement.