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# FDA OKs Amgen’s Herceptin Biosimilar
- URL: https://www.fdaweb.com/fda-oks-amgens-herceptin-biosimilar/
- Published: 2019-06-13T12:00:00.000Z
- Updated: 2026-09-15T01:32:25.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5144336

FDA has approved an Amgen BLA for Kanjinti (trastuzumab-anns), the fifth biosimilar copy of Roche’s Herceptin (trastuzumab). The approval also marks a significant FDA milestone — the 20th biosimilar approved by the agency. This includes at least one biosimilar approved for Avastin, Enbrel, Epogen/Procrit, Herceptin, Humira, Neulasta, Neupogen, Remicade, and Rituxan. Three biological reference products (Avastin, Epogen/Procrit, and Rituxan) have one approved biosimilar. Three (Enbrel, Neulasta, and Neupogen) have two approved biosimilars. Two (Humira and Remicade) have three approved biosimilars. To view Kanjinti’s approved label, click [here](https://www.accessdata.fda.gov/drugsatfda%5Fdocs/label/2019/761073s000lbl.pdf?utm%5Fcampaign=FDA%20Approves%20Kanjinti%20%28trastuzumab-anns%29%2C%20Biosimilar%20to%20Herceptin&utm%5Fmedium=email&utm%5Fsource=Eloqua).