‘Biosimilar’ drug Ogviri approved by FDA for breast and stomach cancer

For the treatment of certain breast and stomach cancers, the U.S. Food and Drug Administration (FDA) recently approved Ogiviri (tastuzumab–dkst), which is the nation’s first biosimilar drug.

FDA said that the newly designed biosimilar are derivative of living organisms and similar to those drugs that had been approved earlier. Moreover, it was found that there is no significant difference between their potency, safety, and purity.

It was reported that Ogviri is approved to treat breast or stomach cancers that are associated with HER2+ gene.

FDA Commissioner, Dr. Scott Gottlieb said, “The FDA continues to grow the number of biosimilar approvals, helping to promote competition that can lower health care costs”. He further added that it is very important to introduce such drugs when the concern is cancer, whose treatment is high costly and can’t be afforded by many.

Certain side effects are expected and reported like headache, chills, fever, diarrhea, nausea, infection, cough, etc.

Like Herceptin, Ogviri box is labeled with a warning stating the risk of heart diseases, serious allergic reactions, lung damage and damage to developing fetus.

Source: drugs.com