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FDA Okays Amgen And Allergan's Kanjinti, Biosimilar To Herceptin

Amgen (AMGN) and Allergan plc (AGN) said that the U.S. Food and Drug Administration approved Kanjinti or trastuzumab-anns for all approved indications of the reference product, Herceptin or trastuzumab for the treatment of HER2-overexpressing adjuvant and metastatic breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.

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.

The company said that Kanjinti is currently not available commercially.

In the U.S., KANJINTI is approved for Adjuvant Breast Cancer, Metastatic Breast Cancer, Metastatic Gastric Cancer.

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