Herceptin Biosimilar Ogivri Receives FDA Approval for Breast and Stomach Cancer

On 1 December 2017, the United States Food and Drug Administration FDA, for HER2 receptor positive (HER2+) breast cancer or metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma), approved trastuzumab-dkst (trade name Ogivri) as a biosimilar to trastuzumab (trade name Herceptin) for the treatment of patients with these cancers.

With this approval, the FDA approved its second biosimilar medicine for cancer treatment. It had previously approved bevacizumab-awwb, a biosimilar to bevacizumab, in September 2017.

The approval is based on extensive structural and functional product characterization, animal data, human pharmacokinetic and pharmacodynamic data, and clinical studies including clinical immunogenicity, comparing Ogivri with Herceptin. These data show that Ogivri is highly similar to Herceptin and that there are no clinically meaningful differences between the products. Ogivri was approved as a biosimilar, rather than as an interchangeable product.

• What is a generic (equivalent) medicine? What does biosimilar mean?

Ogivri’s HER2+ breast cancer treatment may cause side effects including headache, diarrhea, nausea, chills, fever, infection, heart failure, insomnia, cough and rash. In Ogivri treatment for HER2+ metastatic stomach cancer , common side effects include low white blood cell count (neutropenia), diarrhea, fatigue, anemia, mouth sores, weight loss, upper respiratory tract infections, fever, low platelet count, sores in the mouth and esophagus (mucositis and esophagitis), inflammation, throat infection and altered taste. A possible serious side effect of Ogivri is worsening of chemotherapy-induced neutropenia.

Like Herceptin, Ogivri’s prescribing information contains warnings for healthcare professionals and patients about cardiomyopathy (heart muscle damage), allergic infusion reactions, pulmonary side effects and risks of use during pregnancy.