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A new biosimilar to the cancer drug Herceptin, which raked in $2.5 billion in US sales last year, is expected to produce blockbuster sales in the US.
A new biosimilar to the cancer drug Herceptin, which raked in $2.5 billion in United States sales last year, is expected to produce blockbuster sales in the US.
FDA approved trastuzumab-dkst (Ogivri) from Mylan and Biocon, a biosimilar to trastuzumab (Herceptin, Genentech) for the treatment of patients with breast or metastatic stomach cancer whose tumors overexpress the HER2 gene (HER2+).
Ogivri is the first biosimilar approved in the US for the treatment of breast cancer or stomach cancer and the second biosimilar approved in the US for cancer.
Mylan and Biocon said the European Medicines Agency (EMA) has also accepted their resubmitted application for Ogivri.
“Mylan anticipates potentially being the first company to offer a biosimilar to Herceptin, as a result of Mylan’s ability to secure global licenses for its trastuzumab product from Genentech and Roche earlier this year. This milestone secured a clear pathway to commercialize Mylan’s biosimilar to Herceptin in various markets globally," Biocon said in a statement.
“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, in a statement. “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 Ogivri 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 demonstrates Ogivri is biosimilar to Herceptin, according to FDA.
Ogivri has been approved as a biosimilar, not as an interchangeable product.