FDA Approves Fifth Biosimilar of HERCEPTIN

Today, June 13, 2019, the U.S. FDA approved Amgen’s aBLA for KANJINTI (trastuzumab-anns), a biosimilar of Genentech’s HERCEPTIN. According to its approved package insert, KANJINTI, like its reference product, is indicated for the treatment of HER2 overexpressing breast cancer and the treatment of HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.

KANJINTI is the twentieth biosimilar product overall to obtain FDA approval and the fifth trastuzumab biosimilar, following Mylan’s OGIVRI (trastuzumab-dkst) in December 2017, Celltrion’s HERZUMA (trastuzumab-pkrb) in December 2018, Samsung Bioepis’s ONTRUZANT (trastuzumab-dttb) in January 2019, and Pfizer’s TRAZIMERA (trastuzumab-qyyp) in March 2019. No trastuzumab biosimilar is currently on the U.S. market.

Both Amgen and Samsung Bioepis are currently engaged in patent litigation under the BPCIA against Genentech regarding their respective trastuzumab biosimilars. Mylan, Celltrion and Pfizer, in contrast, have each settled their respective trastuzumab patent disputes.