FDA Approves Amgen And Allergan's KANJINTI (trastuzumab-anns), A Biosimilar To Herceptin? (trastuzumab)
Approval Based on Totality of Evidence Demonstrating KANJINTI is Biosimilar to HerceptinThird FDA Approval From Amgen's Biosimilars Portfolio
THOUSAND OAKS, Calif.,?June 13, 2019?/PRNewswire/ --?Amgen?(NASDAQ:AMGN) and?Allergan plc?(NYSE:AGN) today announced that the?U.S. Food and Drug Administration?(FDA) has approved KANJINTI??(trastuzumab-anns) for all approved indications of the reference product, Herceptin??(trastuzumab):? for the treatment of HER2-overexpressing adjuvant and metastatic breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.
"The?FDA?approval of KANJINTI is an important milestone for our biosimilars portfolio, providing an additional treatment option for patients across three types of cancer," said?David M. Reese, M.D., executive vice president of Research and Development at?Amgen. "KANJINTI is the third biosimilar from our portfolio to receive?FDA?approval, highlighting our long-term commitment to providing patients with serious illnesses access to high-quality biological therapies."
KANJINTI was proven to be highly similar to, and to have no clinically meaningful differences from, Herceptin based on a comprehensive totality of evidence which included extensive comparative analytical, pharmacokinetic and clinical data.?At the time of approval, KANJINTI is the only trastuzumab biosimilar to incorporate the evaluation of a single transition in the clinical study, demonstrating similar safety and immunogenicity in patients who were previously on Herceptin.
"KANJINTI is the second of four biosimilars from?Amgen?and?Allergan's?collaboration to be approved by the?FDA," said?David Nicholson, chief research and development officer at?Allergan. "We are proud of the progress being made as we continuously strive to develop and deliver high-quality cancer therapies in collaboration with?Amgen."
Amgen?has a total of 10 biosimilars in its portfolio, three of which have been approved in the U.S. and three that are approved in the?European Union?(EU).
About KANJINTI??(trastuzumab-anns) in the U.S.
KANJINTI is a biosimilar to trastuzumab, a recombinant DNA-derived humanized monoclonal immunoglobulin G1 kappa antibody. The active ingredient of KANJINTI is a humanized monoclonal antibody that has the same amino acid sequence, structure and function as trastuzumab. KANJINTI has the same pharmaceutical dosage form and same strength after reconstitution as trastuzumab.
KANJINTI is currently not available commercially.? This is not an offer for sale.?The following information is derived from the approved label in the U.S.
In the U.S., KANJINTI is approved for:
Adjuvant Breast Cancer
KANJINTI is indicated for adjuvant treatment of HER2-overexpressing node-positive or node-negative (ER/PR-negative or with one high-risk feature*) breast cancer:
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