Amgen/Allergan Announce FDA Approval of Their Trastuzumab Biosimilar

On June 13, the Food and Drug Administration (FDA) approved the fifth trastuzumab biosimilar. This product, Kanjinti (trastuzumab-anns), will be produced through the partnership of Amgen and Allergan.

Originally filed in July 31, 2017, the drug makers received a complete response letter June 1, 2018. Their resubmission resulted in the approval for all indications of the reference product Herceptin®, including:

  • Treatment of HER2-overexpressing breast cancer (in adjuvant nonmetastatic and metastatic settings)
  • Treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.

This trastuzumab biosimilar is approved for use in combination with other specific cancer chemotherapy or as monotherapy. The Kanjinti approval was supported by four open-label clinical trials in over 10,500 women with breast cancer.

Kanjinti was approved by the European Marketing Agency on May 30, 2018 (and is marketed under the Kanjinti name).

No announcement was made as to when Kanjinti will be marketed in the US. None of the other trastuzumab biosimilars are currently available in the US; however, its principal patent expires at the end of June. This should open the door for immediate and aggressive price discounts on both the reference product and its 5 biosimilars for the $2.9 billion US market. No licensing agreements have been announced for Herceptin biosimilars.

This marks the second biosimilar approval for partners Amgen and Allergan. Their bevacizumab biosimilar (Mvasi®) won approval in 2017 and is not yet marketed.  

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