ABP 980: A Trastuzumab Biosimilar.

ABP 980 (KANJINTI™) is a biosimilar of the reference anti-HER2 antibody trastuzumab. In the EU, ABP 980 is approved for use in all indications for which reference trastuzumab is approved, including HER2-positive early breast cancer, metastatic breast cancer and metastatic gastric cancer. ABP 980 has similar physicochemical and functional properties to those of reference trastuzumab, and the pharmacokinetic biosimilarity of the agents has been shown in healthy subjects. In the phase 3 LILAC study, ABP 980 demonstrated similar clinical efficacy (based on central laboratory review sensitivity analysis) and tolerability to that of reference trastuzumab in patients with HER2-positive early breast cancer. The tolerability, immunogenicity and safety profiles of ABP 980 were similar to those of reference trastuzumab, and a single switch from reference trastuzumab to ABP 980 had no impact on the immunogenicity or safety of ABP 980. The role of reference trastuzumab in the management of HER2-positive early breast cancer, metastatic breast cancer and metastatic gastric cancer is well established and ABP 980 provides an effective biosimilar alternative for patients requiring trastuzumab therapy.