FDA Approves Second Biosimilar for Cancer

The US Food and Drug Administration (FDA) approved a biosimilar for trastuzumab (Herceptin). The biosimilar, Ogivri (trastuzumab-dkst), is approved for the treatment of patients with HER2-positive breast cancer or metastatic gastric or gastroesophageal junction adenocarcinoma. Ogivri is the first biosimilar approved in the United States for the treatment of breast cancer or stomach cancer. The FDA originally voted to recommend approval of the biosimilar for the treatment of HER2-positive breast cancer in July, based on data from the phase III HERITAGE study.

“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,” said FDA Commissioner Scott Gottlieb, MD, in a press release. “We’re committed to taking new policy steps to advance our biosimilar pathway and promote more competition for biological drugs.”

The approval was based on a 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 demonstrate that Ogivri is biosimilar to trastuzumab. Ogivri has been approved as a biosimilar, not as an interchangeable product.

Common side effects of Ogivri for the treatment of HER2-positive breast cancer include headache, diarrhea, nausea, chills, fever, infection, congestive heart failure, insomnia, cough, and rash. Common side effects for the treatment of metastatic stomach cancer include neutropenia, diarrhea, fatigue, anemia, stomatitis, weight loss, upper respiratory tract infections, fever, thrombocytopenia, mucosal inflammation, common cold, and dysgeusia.

In addition, similar to labeling for trastuzumab, Ogivri’s label will include a Boxed Warning about the risks for heart disease, infusion reactions, lung damage, and harm to a developing fetus associated with the drug.

The first biosimilar approved in the United States for the treatment of cancer was Mvasi, a biosimilar to bevacizumab (Avastin) for certain colorectal, lung, brain, kidney, and cervical cancers.

Other trastuzumab biosimilars in HER2-positive breast cancer are also under investigation.