The first biosimilar for the treatment of breast and stomach cancer has been approved by the FDA in the US. The FDA has approved a biosimilar to Herceptin, termed Ogivri, which is utilized for the treatment of breast and stomach cancers that overexpress the HER2 gene.
To gain approval, the FDA reviewed evidence of Ogivri including: animal study data, structural and functional characterization, pharmacokinetic and pharmacodynamics data and clinical safety data. After this review, Ogivri was approved as a biosimilar and not as an interchangeable product.
Scott Gottlieb, FDA Commissioner (MD, USA), concluded: “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. We’re committed to taking new policy steps to advance our biosimilar pathway and promote more competition for biological drugs.”