Amneal Pharmaceuticals Inc. on Friday said it received U.S. Food and Drug Administration approval for Flynetra, a biosimilar to Amgen Inc.'s cancer drug Neulasta.
The Bridgewater, N.J., pharmaceutical company said the approval is its third this year for biosimilars used in oncology, adding that it expects to launch the three products over the second half of the year, along with a full patient support program.
Biosimilars are near-copies of biologic drugs, such as Neulasta, that are made from living cells and are analogous to generic copies of traditional medicines.
The FDA has already approved several biosimilar competitors to Neulasta, which is used to reduce the incidence of infection associated with febrile neutropenia, a serious side effect of chemotherapy.
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