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Fulphila (pegfilgrastim) is approved for people with symptoms of febrile neutropenia, which is characterized by fever and other signs of infection such as low white-blood-cell count, the FDA said in a news release. People receiving immune-system suppressing chemotherapy for non-bone marrow cancer are at heightened risk for febrile neutropenia, the agency added.
A "biosimilar" drug, generally derived from a living organism, is approved based on clinical evidence that it is "highly similar" to a product that's already approved by the FDA, and that there's "no clinically meaningful differences" in safety, purity and potency, the agency said.
"We want to make sure that the [method] for developing biosimilar versions of approved biologics is efficient and effective, so that patients benefit from [price] competition to existing biologics once lawful intellectual property has lapsed on these products," FDA Commissioner Dr. Scott Gottlieb said.
The most common side effects of Fulphila are pain in the bones, arms and legs. Less common but more serious adverse reactions include the possibility of spleen rupture, severe respiratory problems and allergic reactions, kidney inflammation, high white blood cell count, tumor growth and "fatal sickle cell [anemia] crises," the FDA said.
Fulphila is produced by Mylan, with U.S. headquarters in Canonsburg, Penn.
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