Medication Monitor

Generic Name (Trade Name—Company)
June 21, 2019


(Kanjinti—Amgen, Allergan)
FDA approves new biosimilar to Herceptin

Amgen and Allergan announced FDA approval of trastuzumab-anns for treatment of HER2-overexpressing adjuvant and metastatic breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. The biosimilar is a recombinant DNA-derived humanized monoclonal immunoglobulin G1 kappa antibody.

Trastuzumab-anns was proven to be highly similar to and to have no clinically meaningful differences from the reference product, trastuzumab (Herceptin), based on extensive comparative analytical, pharmacokinetic, and clinical data.

The biosimilar is the second of four biosimilars from Amgen and Allergan's collaboration to be approved by the FDA.

The most common adverse reactions with treatment for breast cancer are fever, nausea, vomiting, infusion reactions, diarrhea, infections, increased cough, headache, fatigue, dyspnea, rash, neutropenia, anemia, and myalgia.

In metastatic gastric cancer, the most common adverse reactions are neutropenia, diarrhea, fatigue, anemia, stomatitis, weight loss, upper respiratory tract infections, fever, thrombocytopenia, mucosal inflammation, nasopharyngitis, and dysgeusia.