On 18 September 2024, the US Food and Drug Administration (FDA) granted approval for a second strength for Accord’s Hercessi (trastuzumab-strf), a biosimilar referencing Roche’s Herceptin.
Hercessi is now approved in a 420 mg strength to treat Human epidermal growth factor receptor 2 (HER2)-overexpressing breast and gastric or gastroesophageal junction adenocarcinoma. This news comes after the FDA approval of a 150 mg strength on 29 April 2024 [1].
FDA’s approval of a second strength of Hercessi paves the way for Accord BioPharma to commercially launch its first biosimilar in the US in early 2025.
FDA approval for Hercessi was based on analytical, preclinical, and clinical data from three studies, showing it is similar to Herceptin (trastuzumab) in efficacy, safety, and quality. These included two phase I pharmacokinetic (PK) studies in healthy volunteers (HLX02-HV01, HLX02-HV02) and a phase III clinical study in patients with HER2-overexpressing metastatic breast cancer (HLX02-BC01). The data adhered to FDA biosimilar guidelines and showed no clinically meaningful differences in safety or efficacy between HERCESSI and Herceptin, supporting their biosimilarity.
Hercessi (HLX02) was originally developed by Accord's business partner, Shanghai Henlius Biotech, Inc, headquartered in Shanghai, China. In 2021, Henlius granted Accord BioPharma the exclusive rights to develop and commercialize Hercessi in the US and Canada.
Henlius’ trastuzumab biosimilar, Adheroza, was approved in Canada on 22 August 2024, and is also marketed by Accord [2].
Accord BioPharma, the US specialty division of Intas Pharmaceuticals Ltd, is focused on the development of oncology, immunology, and critical care therapies.
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References
1. GaBI Online - Generics and Biosimilars Initiative. FDA approves ustekinumab, trastuzumab, and tocilizumab biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Oct 23]. Available from: www.gabionline.net/biosimilars/news/fda-approves-ustekinumab-trastuzumab-and-tocilizumab-biosimilars
2. GaBI Online - Generics and Biosimilars Initiative. Canada approves trastuzumab Adheroza and ustekinumab Steqeyma biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Oct 23]. Available from: www.gabionline.net/biosimilars/news/canada-approves-trastuzumab-adheroza-and-ustekinumab-steqeyma-biosimilars
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