First biosimilar for the treatment of certain breast and stomach cancers approved by FDA

The US Food and Drug Administration (FDA) has approved the first biosimilar for the treatment of certain breast and stomach cancers, Ogivri (trastuzumab-dkst).

Ogivri is a biosimilar to Herceptin (trastuzumab) and is approved for the treatment of patients with breast or metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma) whose tumours overexpress the HER2 gene (HER2+).

“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,” revealed FDA Commissioner Dr Scott Gottlieb. “We’re committed to taking new policy steps to advance our biosimilar pathway and promote more competition for biological drugs.”

This approval has been based upon a review of evidence, including extensive structural and functional characterisation, animal study data, human pharmacokinetic and pharmacodynamics data, clinical immunogenicity data and other clinical safety and effectiveness data that demonstrates Ogivri is biosimilar to Herceptin.

This product has been approved as a biosimilar and not an interchangeable product. The FDA granted approval of Ogivri to Mylan.