HLX02, a proposed trastuzumab (Herceptin) biosimilar, has had its biologics license application (BLA) accepted by the FDA. The treatment has been proposed as an adjuvant therapy for HER2-overexpressing breast cancer, HER2-overexpressing metastatic breast cancer, and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.1
The BLA is based on comparative structural and functional analytical data that used orthogonal techniques and head-to-head clinical studies between HLX02 and reference trastuzumab. Nonclinical studies, a phase 1 pharmacokinetic similarity study, and a global multicenter, phase 3 trial (NCT03084237) evaluating safety, efficacy, and immunogenicity for HLX02 and reference trastuzumab were also included in the BLA. Clinical results demonstrated high similarity in quality, safety, and efficacy between HLX02 and reference trastuzumab.