Biosimilar Seen to Match Herceptin in Treating Advanced Breast Cancer in Clinical Trial

Biosimilar Seen to Match Herceptin in Treating Advanced Breast Cancer in Clinical Trial
A Phase 3 clinical trial comparing Mylan’s proposed biosimilar trastuzumab with the original Herceptin (trastuzumab) found no difference between the drugs in effectiveness or safety, suggesting that the biosimilar may be a viable option for women with ERBB2-positive metastatic breast cancer. Biosimilars are copies of biological drugs that show comparable effects to the original compound, and research shows that such compounds both increase access and reduce costs for treatment. Mylan plans to conduct further studies to assess how the biosimilar performs in the long run. The study, "Effect of a Proposed Trastuzumab Biosimilar Compared With Trastuzumab on Overall Response Rate in Patients With ERBB2 (HER2)–Positive Metastatic Breast Cancer," was published in the journal JAMA. The clinical trial (NCT02472964) randomized 500 women to receive either Herceptin or the biosimilar, combined with chemotherapy with either Taxol (paclitaxel) or Taxotere (docetaxel). Nearly an equal number received the proposed biosimilar as were given Herceptin, with 230 and 228 women in each group. After the initial 24 weeks, women with a stable disease continued treatment with the biological drug only for an additional 24 weeks. Researchers from the University of California San Francisco and Mylan report
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