Biosimilar to Genentech’s Herceptin Wins FDA Approval

The FDA has approved Ogivri as a biosimilar to Herceptin for the treatment of patients with breast or metastatic stomach cancer whose tumors overexpress the HER2 gene. Ogivri is the first biosimilar approved in the U.S. for the treatment of breast cancer or stomach cancer and the second biosimilar approved in the U.S. for the treatment of cancer. The FDA granted approval of Ogivri to Mylan GmbH; Herceptin was approved in September 1998 and is manufactured by Genentech.

“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, M.D. “We’re committed to taking new policy steps to advance our biosimilar pathway and promote more competition for biological drugs.”

Biological 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 biological product that is approved based on data showing that it is highly similar to a biological product already approved by the FDA (i.e. the reference product) and has no clinically meaningful differences in terms of safety, purity and potency from the reference product, in addition to meeting other criteria specified by law.

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. Ogivri has been approved as a biosimilar, not as an interchangeable product. (Source: FDA Website, December 01, 2017)