HLX 02 trastuzumab biosimilar is filed at EMA
Shanghai Henlius Biotech announced on 21 June 2019 that the regulatory submission for its proposed trastuzumab biosimilar (HLX 02) had been accepted by the European Medicines Agency (EMA). Trastuzumab is a monoclonal antibody that interferes with the human epidermal growth factor receptor 2 (HER2)/neu receptor. In some cancers, notably certain types of breast cancer, HER2 is overexpressed, and causes cancer cells to reproduce uncontrollably.
Trastuzumab is therefore used to treat certain breast cancers. Henlius also reported that the new drug application (NDA) for HLX 02 had been accepted for review by the National Medical Products Administration (NMPA) in China.
The EU patents on trastuzumab expired in July 2014.
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