Celltrion said Friday that it has presented the results of the clinical safety trials for Herzuma (Original: Herceptin) at the European Society for Medical Oncology (EMSO).
Herzuma is an anti-cancer antibody biosimilar used for the treatment of breast and stomach cancer. Celltrion received approval from the Ministry of Food and Drug Safety식품의약품안전처 in 2014.
The company applied for a global clinical trial for early breast cancer patients and also asked for sales approval to the European Medicines Agency (EMA) last October.
It conducted the global clinical trial in 22 countries around the world, including France and Italy, from June 2014. A total of 549 patients with HER2 overexpression breast cancer enrolled in the trial.
Patients were divided randomly into two groups and either given Herzuma or Herceptin with Docetaxel and FEC combination therapy. They received a total of eight injections at three-week intervals before surgery and 10 injections at three-week intervals as a single-agent therapy after surgery.
Researchers compared the total pathological complete response rate, which signified the complete removal of the breast and axillary lymph node tumors, from the time of the surgery.
The researchers found that the pathologic complete remission rate of 46.8 percent for those treated with Herzuma and 50.4 percent for those treated with Herceptin.
Herzuma showed equivalent efficacy and safety as the original, satisfying the margins for the equivalence of the proportion verification and differential verification set by the U.S. Food and Drug Administration and EMA
“Herzuma proved the same equivalent efficacy and safety, which is the biosimilar licensing screening standard, like those of the original drug, and emerged as a treatment for the complete removal of the breast and axillary lymph node tumors,” a company official said. “After analyzing the clinical results of the competing Herceptin biosimilar, we are confident that medical staffs around the world can prescribe Herzuma.”
Celltrion셀트리온 plans to come up with various strategies to target U.S. and European markets.
The original product Herceptin, developed by Genentech 제넨택 and sold by Roche 로슈, is a global blockbuster drug with an annual sale of 7.9 trillion won ($7 billion).
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