Posted by Michael Wonder on 15 Feb 2023
Henlius announces US FDA acceptance of biologics license application for proposed biosimilar trastuzumab HLX02
14 February 2023 - The first Chinese biosimilar approved in both China and the EU, and potentially to be approved in the US.
Shanghai Henlius Biotech announced that the US FDA has accepted the biologics license application for Henlius’ HLX02 (trastuzumab for injection, trade name in Europe: Zercepac, trade name in China: Hanquyou; trade names in Australia: Tuzucip and Trastucip) submitted by the company’s business partner Accord BioPharma.
