The FDA announced Thursday that it has approved Amgen's Kanjinti (trastuzumab-anns), a biosimilar referencing Roche's Herceptin (trastuzumab), for HER-2 overexpressing breast cancer, as well as for HER-2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. "It is the fifth FDA-approved biosimilar to Herceptin, a remarkable development in and of itself, since about four years ago, there were no biosimilars approved in the US," noted Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research.
Data from the Phase III LILAC study  unveiled in 2016 showed that Kanjinti, also known as ABP 980, was non-inferior to Herceptin in patients with HER2-positive early breast cancer. Amgen and partner  Allergan, formerly Watson Pharmaceuticals, indicated at the time that the data "could not rule out superiority" based on the study's primary efficacy endpoint.
The FDA had initially issued a complete response letter for the Kanjinti filing  in 2018. Commenting at the time, Amgen said it would work closely with the agency and that it did not expect the decision "to impact our US launch plan."
The other four Herceptin biosimilars currently approved in the US include Pfizer's Trazimera  (trastuzumab-qyyp), Merck & Co. and Samsung Bioepis' Ontruzant  (trastuzumab-dttb), Celltrion's Herzuma  (trastuzumab-pkrb) and Mylan and Biocon's Ogivri  (trastuzumab-dkst). Amgen and Allergan said last year that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) had issued a positive opinion  for Kanjinti to treat HER2-positive metastatic breast cancer, HER2-positive early breast cancer and HER2-positive metastatic adenocarcinoma of the stomach or gastroesophageal junction.
Meanwhile, Peter Marks, director of the FDA's Center for Biologics, Evaluation and Research, acknowledged that "the US market for biosimilars is still maturing" and that there is "much more work to be done toward building the robust competitive environment we envision for biosimilars." The agency launched a Biosimilar Action Plan  last year, and more recently released draft guidance  for industry on the design and evaluation of comparative analytical studies for biosimilarity.