Herceptin Biosimilar Approved in the U.S.

Kanjinti (trastuzumab-anns) from Amgen and Allergan receives FDA approval for breast cancer.

Trastuzumab is a humanized monoclonal antibody originally developed by Roche under the trade name Herceptin for the treatment of breast cancer. The U.S. Food and Drug Administration (FDA) recently approved the fifth biosimilar of trastuzumab ––from Amgen and Allergan. Kanjinti (trastuzumab-anns) is approved for the treatment of HER2-overexpressing adjuvant and metastatic breast cancer and HER2-overexpressing metastatic, gastric or gastroesophageal junction adenocarcinoma.

The drug is the third Amgen biosimilar to be approved by the FDA and the second of four biosimilars being jointly developed by Amgen and Allergan via a collaboration initiated in December 2011. According to the two companies, Kanjinti obtained similar responses to Herceptin based on evidence from comparative, analytical, pharmacokinetic (PK) and clinical data. It is offered in the same pharmaceutical dosage form and strength as trastuzumab after reconstitution.

Emilie Branch

Emilie is responsible for strategic content development based on scientific areas of specialty for Nice Insight research articles and for assisting client content development across a range of industry channels. Prior to joining Nice Insight, Emilie worked at a strategy-based consulting firm focused on consumer ethnographic research. She also has experience as a contributing editor, and has worked as a freelance writer for a host of news and trends-related publications