Aisling McGuigan
HLX11 (pertuzumab-dpzb in the USA), marketed as POHERDY® in the USA and EU and as HANBEIYOU® in China, is a biosimilar of reference pertuzumab, an anti-human epidermal growth factor 2 (HER2) monoclonal antibody. It is approved for use in the same indications as reference pertuzumab: early or metastatic HER2-positive breast cancer. The physicochemical and functional properties of HLX11 are similar to reference pertuzumab, and pharmacokinetic equivalence has been shown in healthy individuals. HLX11 demonstrated equivalent clinical efficacy to EU-sourced reference pertuzumab in the neoadjuvant treatment of patients with HER2-positive, hormone-receptor negative, early stage or locally advanced breast cancer. The tolerability, safety and immunogenicity profiles of the two agents were also similar. No new safety or immunogenicity concerns were observed following a switch from neoadjuvant reference pertuzumab to adjuvant HLX11. The role of reference pertuzumab in the management of HER2-positive breast cancer is well established, and HLX11 provides an effective biosimilar alternative for patients requiring pertuzumab therapy.