USFDA Approves Amgen’s Trastuzumab Biosimilar, Kanjinti

The FDA has approved Amgen’s ABP 980, a trastuzumab biosimilar referencing Herceptin. The drug, trastuzumab-anns, will be sold as Kanjinti.

Kanjinti was approved for the treatment of HER2-positive breast cancer and gastric cancer.

KANJINTI was proven to be highly similar to, and to have no clinically meaningful differences from, Herceptin based on a comprehensive totality of evidence which included 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.

“KANJINTI is the second of four biosimilars from Amgen and Allergan’s collaboration to be approved by the FDA,” said David Nicholson, chief research and development officer at Allergan. “We are proud of the progress being made as we continuously strive to develop and deliver high-quality cancer therapies in collaboration with Amgen.”

Amgen has a total of 10 biosimilars in its portfolio, three of which have been approved in the U.S. and three that are approved in the European Union (EU).