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A safety study of a locally made copy of trastuzumab in 597 Iranian women treated after breast cancer surgery, whose authors judged it generally well tolerated.
AryoGen Pharmed followed women with HER2-positive non-metastatic breast cancer who received its trastuzumab, AryoTrust, every three weeks for nine cycles after adjuvant chemotherapy, at 15 Iranian sites listed on ClinicalTrials.gov, from February 2017 to August 2022. The 2024 report in Expert Opinion on Drug Safety covers 597 women and 5,313 injection cycles: 139 had at least one adverse event, the commonest being decreased ejection fraction (5.7%), peripheral neuropathy (5.36%) and nausea (5.19%); meningioma was the only life-threatening serious event and the mean ejection fraction did not change notably.
Shares Biosimilar manufacturing and comparability, Biosimilar, Trastuzumab, HER2.
Shares AryoGen Pharmed, Biosimilar manufacturing and comparability, Biosimilar.
Shares AryoGen Pharmed, Biosimilar manufacturing and comparability, Biosimilar, HER2-positive breast cancer.
Shares Biosimilar, Trastuzumab, HER2, HER2-positive breast cancer.
Shares AryoGen Pharmed, Biosimilar manufacturing and comparability, Biosimilar, Trastuzumab.
Shares AryoGen Pharmed, Biosimilar.
Shares Biosimilar manufacturing and comparability, Biosimilar, HER2-positive breast cancer.
Shares Trastuzumab, HER2, HER2-positive breast cancer.
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