Breaking: FDA Approves First Biosimilar for Breast, Stomach Cancer


The US Food and Drug Administration (FDA) has granted approval to a biosimilar for trastuzumab (Herceptin) for the treatment of HER2-positive breast cancer and metastatic stomach cancer.

Trastuzumab-dkst (Ogivri, Genentech) is the first biosimilar approved in the United States for the treatment of breast cancer or stomach cancer and the second biosimilar approved in the United States for cancer.

“The FDA continues to grow the number of biosimilar approvals, helping to promote competition that can lower health care costs. This is especially important when it comes to diseases like cancer, that have a high cost burden for patients,” said Scott Gottlieb, MD, FDA Commissioner, in a press release (December 1, 2017). “We’re committed to taking new policy steps to advance our biosimilar pathway and promote more competition for biological drugs.”


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FDA approval of trastuzumab-dkst came following the review of evidence that included structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamic data, clinical immunogenicity data and other clinical safety and effectiveness data.

Similar to Herceptin, trastuzumab-dkst contains a Boxed Warning regarding increased risks of heart disease, infusion reactions, lung damage, and harm to a developing fetus.—Zachary Bessette