Human therapeutic company Amgen (NASDAQ:AMGN) and Allergan plc (NYSE:AGN) on Thursday jointly announced the receipt of approval from the US Food and Drug Administration (FDA) for KANJINTI (trastuzumab-anns) for all approved indications of the reference product, Herceptin (trastuzumab).

This includes HER2-overexpressing adjuvant and metastatic breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.

According to the partners, KANJINTI is a biosimilar to trastuzumab, a recombinant DNA-derived humanized monoclonal immunoglobulin G1 kappa antibody. The active ingredient of KANJINTI is a humanized monoclonal antibody that has the same amino acid sequence, structure and function as trastuzumab.

The drug, which has the same pharmaceutical dosage form and same strength after reconstitution as trastuzumab, was proven to be highly similar to, and to have no clinically meaningful differences from, Herceptin based on a comprehensive, extensive, comparative analytical, pharmacokinetic and clinical data.

At the time of approval, KANJINTI is the only trastuzumab biosimilar to incorporate the evaluation of a single transition in the clinical study, demonstrating similar safety and immunogenicity in patients who were previously on Herceptin. This is the third FDA approval from Amgen's biosimilars portfolio.