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FDA Approves Biosimilar to Trastuzumab for HER2-Positive Breast Cancer

By: Sarah Jackson
Posted: Friday, December 1, 2017

On December 1, 2017, the U.S. Food and Drug Administration (FDA) approved trastuzumab-dkst (Ogivri) as a biosimilar to trastuzumab (Herceptin) for the treatment of patients with breast or metastatic gastric cancer whose tumors overexpress HER2. The drug is the first biosimilar approved in the United States for the treatment of breast cancer or stomach cancer and the second FDA-approved biosimilar for the treatment of cancer.

The FDA’s approval of trastuzumab-dkst is based on review of evidence that included extensive structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamic data, clinical immunogenicity data, and other clinical safety and effectiveness data that demonstrated trastuzumab-dkst as a biosimilar to trastuzumab. Trastuzumab-dkst has been approved as a biosimilar, not as an interchangeable product.

The most common expected side effects of trastuzumab-dkst for the treatment of HER2-positive breast cancer include headache, diarrhea, nausea, chills, fever, infection, congestive heart failure, insomnia, cough, and rash. Serious expected side effects of trastuzumab-dkst include worsening of chemotherapy-induced neutropenia.