Organon (OGN) and Shanghai Henlius Biotech said Friday the European Medicines Agency has validated the marketing authorization application for HLX11, an investigational biosimilar of breast cancer drug Perjeta, or pertuzumab.
The companies said that in several countries and regions, pertuzumab in combination with trastuzumab and chemotherapy has been approved for breast cancer treatment.
They said the submission was based on a phase 3 clinical study that showed HLX11 meeting the primary endpoint of the total pathological complete response rate evaluated by an Independent Review Committee.
The study, which compared the efficacy and safety of HLX11 with reference Perjeta, also showed that other secondary endpoint indicators were also comparable between the two groups, the companies said.
Henlius granted Organon the exclusive commercialization rights to two biosimilar candidates, including HLX11, under a 2022 license and supply agreement that covers markets such as the US, the EU and Canada, the companies said.
An exception to the deal is China, according to the companies.
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