Phase 3 LILAC study sets standard for clinical evaluation of oncology biosimilars

ABP 980 (Amgen Inc, Thousand Oaks, CA, USA) is a biosimilar of trastuzumab, the recombinant humanized monoclonal antibody against human epidermal growth factor receptor-2 (HER-2), which is overexpressed in 15-30% of patients with breast cancer [1, 2] and 10-30% of patients with gastric tumors [2]. ABP 980 (KANJINTI？, Amgen Europe B.V., The Netherlands) was approved by the European Medicines Agency in March 2018 for the same indications as the originator biologic or reference product (RP), Herceptin？ (trastuzumab; Roche Registration GmbH, Germany), including treatment of HER2-positive (HER2+) metastatic breast cancer, HER2+ early breast cancer and HER2+ metastatic adenocarcinoma of the stomach or gastroesophageal junction [3, 4]