On April 29, 2024, Accord BioPharma, Inc. announced that the U.S. Food and Drug Administration (FDA) approved HERCESSI (trastuzumab-strf). HERCESSI is a biosimilar to HERCEPTIN (trastuzumab) and is indicated for adjuvant treatment of HER2-overexpressing breast cancer, the treatment of HER2-overexpressing metastatic breast cancer, and the treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. Chrys Kokino, U.S. president of Accord, said: “[t]he approval of HERCESSI—our first biosimilar to be approved in the U.S.—marks an important milestone for Accord BioPharma in our efforts to improve access for patients[.]”
HERCESSI is the 6th trastuzumab biosimilar approved by the FDA.
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