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The first biosimilar for the treatment of breast and stomach cancers has been approved by the US Food and Drug Administration (FDA).
The FDA has authorised Ogivri (trastuzumab-dkst) as a biosimilar to Herceptin (trastuzumab) for the treatment of patients with breast or metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma) whose tumours over-express 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 the treatment of cancer, the agency said.
FDA commissioner Scott Gottlieb said: “The FDA continues to grow the number of biosimilar approvals, helping to promote competition that can lower healthcare 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,” he added.
The FDA said Ogivri has been approved as a biosimilar, not as an interchangeable product, and it highlighted the fact that, like Herceptin, the labelling for Ogivri contains a boxed warning to alert healthcare professionals and patients about increased risks of heart disease, infusions reactions, lung damage and harm to a developing foetus.
