Kanjinti Approved as Biosimilar for Herceptin
June 13, 2019 – The U.S. FDA has approved Kanjinti™ (trastuzumab-anns), manufactured by Amgen and Allergan, as a biosimilar for Roche’s Herceptin® (trastuzumab). Kanjinti is the fifth Herceptin biosimilar to receive FDA approval, and is indicated to treat HER2-overexpressing metastatic breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. It is also indicated as an adjuvant treatment for HER2-overexpressing node-positive or node-negative (ER/PR-negative or with one high-risk feature) breast cancer.
In a clinical study, Kanjinti demonstrated similar safety and immunogenicity (the ability to provoke an immune response) in patients who were previously on Herceptin. Analysis of comparative analytical, pharmacokinetic, and clinical data found Kanjinti to be highly similar to and have no clinically meaningful differences from Herceptin.
Recommended dosing varies based on the indication. Kanjinti is administered via intravenous (IV) infusion, and carries a black box warning for cardiomyopathy, infusion reactions, embryo-fetal toxicity, and pulmonary toxicity.
At present, Amgen and Allergan have not released launch or pricing plans.