US approves first biosimilar for certain breast, stomach cancers
The US Food and Drug Administration (FDA) said Friday it has approved the first biosimilar for the treatment of certain breast or stomach cancers, Xinhua reports.
The FDA said in a statement it has approved Ogivri as a biosimilar to Herceptin, a drug that earned 2.5 billion dollars in the US market last year for Swiss company Roche, to treat patients with breast or metastatic stomach cancer whose tumors overexpress the HER2 gene.
The approval also marked the second time a biosimilar has been given green light in the US for the treatment of cancer.
"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.
"We're committed to taking new policy steps to advance our biosimilar pathway and promote more competition for biological drugs."
The FDA granted approval of Ogivri to American-based Mylan GmbH. Herceptin was approved in September 1998 and is manufactured by Genentech, a member of the Roche Group.
Biological products are generally derived from a living organism and can come from many sources, such as humans, animals, microorganisms or yeast.
Biosimilars are cheaper copycat versions of the already approved biological products and according to the FDA, they have no clinically meaningful differences in terms of safety, purity and potency.