Annals of Unintended Consequences: How FDA regulations undermine the biosimilar marketplace and the BPCIA

FDA accelerated approval of Ziihera (zanidatamab-hrii) 50mg/mL for injection for intravenous use for the treatment of adults with previously treated, unresectable or metastatic HER2-positive biliary tract cancer, as detected by an FDA-approved test. Ziihera was approved under accelerated approval based on a 52% objective response rate and a median duration of response of 14.9 months as determined by independent central review. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. The phase III HERIZON-BTC-302 confirmatory trial is ongoing to evaluate zanidatamab in combination with standard-of-care therapy versus standard-of-care therapy alone in the first-line setting for patients with HER2-positive BTC.

FDA has accepted Bayer’s supplemental new drug application for the oral androgen receptor inhibitor Nubeqa (darolutamide) in combination with androgen deprivation therapy for the treatment of patients with metastatic hormone-sensitive prostate cancer.