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An Iranian phase 3 trial that found a locally made copy of bevacizumab worked as well as the original in bowel cancer that had spread.
AryoGen Pharmed's trial randomised patients with metastatic colorectal cancer 2:1 to its bevacizumab (5 mg/kg, called BE1040V in the paper and Stivant on ClinicalTrials.gov) or the originator Avastin, each with FOLFIRI-3 chemotherapy every two weeks for a year. ClinicalTrials.gov lists 22 sites, all in Iran, in Tehran, Mashhad, Isfahan, Shiraz, Rasht, Kermanshah, Ahvaz, Hamadan and Yazd; the trial ran from October 2016 to July 2018 and enrolled 126 patients.
In the 2020 report in Clinical Therapeutics, progression-free survival was 232 days (7.7 months) with the biosimilar and 210 days (7 months) with the reference product; the hazard ratio was 0.79 (90% CI 0.46 to 1.35), whose upper limit was under the non-inferiority margin of 1.44. Overall survival, response rate and safety did not differ significantly.
Shares AryoGen Pharmed, Biosimilar manufacturing and comparability, Biosimilar.
Shares AryoGen Pharmed, Biosimilar manufacturing and comparability, Biosimilar.
Shares AryoGen Pharmed, Biosimilar manufacturing and comparability, Biosimilar, Bevacizumab.
Shares AryoGen Pharmed, Biosimilar.
Shares Biosimilar manufacturing and comparability, Bevacizumab, Colorectal cancer.
Shares Biosimilar manufacturing and comparability, Biosimilar.
Shares Biosimilar manufacturing and comparability, Biosimilar.
Shares Biosimilar, Bevacizumab.
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