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FDA approves first biosimilar for treatment of certain breast, stomach cancers


(NEW YORK) — The U.S. Food and Drug Administration approved a first-of-its-kind drug for the treatment of breast or stomach cancer on Friday.

“The FDA continues to grow the number of biosimilar approvals, helping to promote competition that can lower health care costs,” Commissioner Scott Gottlieb said. A biosimilar is a product, derived from a living organism, that is highly similar to a product already approved by the FDA with no meaningful difference in safety, purity or potency.

The drug, Ogivri, was approved based on its similarity to Herceptin, which was approved by the agency in September 1998.

Side effects of Ogivri are expected to include headache, diarrhea, chills, fever, infection, congestive heart failure, insomnia, cough, rash and low red and/or white blood cell levels.

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