On 18 September 2024, Accord BioPharma announced that the FDA has approved a 420mg strength of its Hercessi™ (trastuzumab-strf), biosimilar to Roche’s Herceptin®, for HER2-overexpressing breast and gastric or gastroesophageal junction adenocarcinoma.
Hercessi™ was FDA-approved in a 120mg dosage form in April 2024. Accord plans to launch Hercessi™ in the US in early 2025 as the company’s first biosimilar.
Hercessi™ (HLX02) was developed by Shanghai Henlius Biotech, with Henlius granting Accord the exclusive rights to develop and commercialise the trastuzumab biosimilar in the US and Canada in 2021. Canadian approval for the biosimilar, where it is marketed as Adheroza™, was granted in August 2024.
HLX02 (150mg) was approved 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.