The FDA greenlights Mylan and Biocon's Ogiviri biosimilar. 

The FDA has approved Mylan’s Ogiviri as the biosimilar to Herceptin (trastuzumab), a treatment for patients with breast or metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma) with tumors overexpressing the HER2 gene (HER2+).

The first biosimilar to be approved for stomach and breast cancer, the FDA said Mylan’s generic is only the second biosimilar to be approved in the U.S. to treat cancer. According to regulators, Ogiviri’s approval was based on a review of evidence that included structural and functional characterization, animal study data and human pharmacokinetic and pharmacodynamic data. The FDA noted that along with clinical immunogenicity and clinical safety data, Ogiviri demonstrated its biosimilarity to Herceptin, which was innovated by Genentech and approved in 1998.

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

Mylan CEO Heather Bresch, commented on the development: "The approval of Ogivri represents a monumental achievement for Mylan to increase patient access to biosimilars and deliver significant savings to the U.S. healthcare system. It will allow us to bring this important biosimilar – the first of its kind – to market in the U.S., expanding cancer-patient access to more affordable treatment.”

Bresch explained that as one of the nation's leading suppliers of cancer medicines, Mylan is excited to add to its portfolio. “Ogivri is one of many biosimilars in our robust pipeline that we look forward to introducing in the coming years as part of our ongoing commitment to increasing access to important medicines for patients."