Henlius is First to have China-Developed Biosimilar Accepted for EU Review

Henlius
Published on: Jun 21, 2019
Author: Amy Liu

Shanghai Henlius, a biosimilar/innovative biologics subsidiary of Fosun Pharma, reported the European Medicines Agency (EMA) has accepted its Marketing Authorization Application of a Herceptin (trastuzumab) biosimilar for review. The company says HLX02 is the first China-developed biosimilar to achieve this milestone, as well as the first China-developed trastuzumab biosimilar accepted in China. The candidate is indicated for HER2+ breast cancer and untreated HER2+ metastatic gastric/gastroesophageal junction (GEJ) cancer. Henlius has out-licensed European rights for HLX02 to Accord Healthcare.

Source: China Biotoday

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