The U.S. FDA approved Ogivri, a biosimilar treatment for Roche’s drug Herceptin, used in the treatment of breast and metastatic stomach cancer. whose tumors express the HER2 gene (HER2+).
Biosimilars also called biological drugs which are less costly. The biosimilars used to treat a several diseases such as cancer, rheumatoid arthritis, diabetes, and anemia. But they are different from generics.
This newly approved drug made by Mylan. It is the first biosimilar treatment approved in the U.S. for the treatment of breast and stomach cancers and the second biosimilar treatment approved in the U.S. for the treatment of cancer.
“The FDA continues to grow the several biosimilar treatment 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.”
Generally, biological products come from many sources, such as humans, animals, micro-organisms or yeast.
The approval of Ogivri is based on clinical safety measurements such as functional characterization, animal study data, human pharmacokinetic and pharmacodynamic data, clinical immunogenicity data.
However, Ogivri is biosimilar to Herceptin. The side effects of Ogivri for the treatment of HER2+ (gene) breast cancer include headache, diarrhea, nausea, chills, fever, infection, congestive heart failure, insomnia, cough and rash.
Common side effects of Ogivri for the treatment of HER2+ metastatic stomach cancer include neutropenia, diarrhea, fatigue, anemia, stomatitis, weight loss, upper respiratory tract infections, fever, thrombocytopenia, mucosal inflammation, common cold and unusual taste sensation (dysgeusia).
Similar to Herceptin, the Ogivri contains a warning alert about risks of heart disease, infusions reactions, lung damage and harm to a developing fetus.
Patients should stop taking Ogivri if cardiomyopathy, life-threatening allergic reactions (anaphylaxis), angioedema, inflammation of the lungs or fluid in the lungs (acute respiratory distress syndrome) occur.
Patients should advise of the potential risk to a developing fetus and to use effective agent.