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FDA Recent Approval of Kanjinti (Biosimilar to Herceptin)

Last month, the FDA approved Kanjinti, the 5th biosimilar to Herceptin. Kanjinti is approved for the treatment of HER2-overexpressing adjuvant and metastatic breast cancer.1,2

What is Kanjinti?

Kanjinti is a HER2 receptor antagonist that is a biosimilar to trastuzumab (Herceptin). Studies found that Kanjinti had no clinically meaningful differences to Herceptin. Kanjinti was developed as a collaboration between Amgen and Allergan but is not currently commercially available.2

What is a biosimilar?

Biosimilars are biological products that have been shown to be highly similar to an already-approved product. Biosimilars must have no clinically meaningful differences from their reference products with regard to effectiveness or safety and only small differences in clinically inactive components are allowable.3

  1. Prescribing Information for Kanjinti. Available at https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761073s000lbl.pdf
  2. FDA Approves Amgen And Allergan's KANJINTI™ (trastuzumab-anns), A Biosimilar to Herceptin® (trastuzumab). Available at https://www.amgen.com/media/news-releases/2019/06/fda-approves-amgen-and-allergans-kanjinti-trastuzumabanns-a-biosimilar-to-herceptin-trastuzumab/
  3. FDA approves Kanjinti, biosimilar to Herceptin, Available at https://www.healio.com/hematology-oncology/breast-cancer/news/online/%7B50daabf4-aa96-4741-ab31-bb0a4d148494%7D/fda-approves-kanjinti-biosimilar-to-herceptin.

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