European Medicines Agency Accepted First "China-Developed" Biosimilar - Henlius HLX02 Marketing Authorization Application for Review
Henlius trastuzumab biosimilar HLX02 has been accepted by the European Medicines Agency (EMA) for reviewing its Marketing Authorization Application (MAA). HLX02 has established three "Firsts" both in China and globally.
- First?China?biosimilar conducted a multi-center, international phase 3 clinical trial
- First trastuzumab developed in?China?following the National Medical Products Administration (NMPA) technical guideline for biosimilar with the New Drug Application (NDA) received the acceptance for review from the NMPA
- First?China-developed trastuzumab biosimilar accepted for MAA review by the EMA