Henlius Trastuzumab Receives FDA Approval in the United States | Taiwan News taiwannews.com.tw - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from taiwannews.com.tw Daily Mail and Mail on Sunday newspapers.
The FDA has approved Hercessi for the adjuvant treatment of HER2-overexpressing breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.
The timing is ripe for a robust biosimilar market in China, given the rapid increase of novel biologics approved to treat cancer and inflammatory diseases in the country over the past decade and the looming patent cliffs for several established biologics. As of December, the NMPA had approved more than 20 biosimilars that were developed in China. Most of those referenced just two biologics – Roche AG’s cancer drug Avastin (bevacizumab) and Abbvie Inc.’s immunology drug Humira (adalimumab). In 2022, the oncology and immunology biosimilar market in China garnered sales of about $2 billion, according to Clarivate estimates. To reach their full potential in China though, biosimilars must win over prescribers and patients.
/PRNewswire/ Shanghai Henlius Biotech, Inc. (2696.HK) announced that the NDA for new indication of HANSIZHUANG, serplulimab, an innovative anti-PD-1 mAb.