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 or gastroesophageal junction adenocarcinoma whose tumors overexpress the HER2 gene. 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.
Scott Gottlieb, MD
“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 FDA Commissioner Scott Gottlieb, MD. “We’re committed to taking new policy steps to advance our biosimilar pathway and promote more competition for biological drugs.”
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 demonstrate trastuzumab-dkst is biosimilar to trastuzumab. Trastuzumab-dkst has been approved as a biosimilar, not as an interchangeable product.
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, difficulty sleeping (insomnia), cough, and rash. Common expected side effects of trastuzumab-dkst for the treatment of HER2-positive metastatic stomach cancer include neutropenia, diarrhea, fatigue, anemia, stomatitis, weight loss, upper respiratory tract infections, fever, thrombocytopenia, mucosal inflammation, nasopharyngitis, and dysgeusia. Serious expected side effects of trastuzumab-dkst include worsening of chemotherapy-induced neutropenia.
We’re committed to taking new policy steps to advance our biosimilar pathway and promote more competition for biological drugs.—
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Like trastuzumab, the labeling for trastuzumab-dkst contains a boxed warning to alert health-care professionals and patients about increased risks of cardiomyopathy, infusion reactions, pulmonary toxicity, and embryofetal toxicity. Patients should stop taking trastuzumab-dkst if cardiomyopathy, anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome occur. Patients should be advised of the potential risk to a developing fetus and to use effective contraception.
Health-care professionals should review the prescribing information in the labeling for detailed information about the approved uses.
Biologic products are generally derived from a living organism and can come from many sources, such as humans, animals, microorganisms, or yeast. A biosimilar is a biologic product that is approved based on data showing that it is highly similar to a biologic product already approved by the FDA (reference product) and has no clinically meaningful differences in terms of safety, purity, and potency (ie, safety and effectiveness) from the reference product, in addition to meeting other criteria specified by law.
The FDA granted approval of trastuzumab-dkst to Mylan GmbH. Trastuzumab was approved in September 1998 and is manufactured by Genentech, Inc.
For more information, visit FDA.gov. ■