On 22 August 2024, Shanghai Henlius Biotech announced that its partner, Intas subsidiary Accord Healthcare, has received marketing approval from Health Canada for HLX02, the Henlius-developed biosimilar to Roche’s Herceptin® (trastuzumab) to treat early/metastatic breast cancer and metastatic gastric cancer. HLX02 is marketed in Canada under the name Adheroza.
HLX02 (150mg) was approved in the US as Hercessi™ in April 2024 and in Australia in July 2022 (marketed by Cipla under the names Tuzucip™ and Trastucip™). It has been sold as Zercepac™ in Europe (approved July 2020) and HANQUYOU in China (approved August 2020).
The first trastuzumab biosimilar was approved in the US in December 2017 and in the EU in November 2017.