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Mylan, Biocon bag US FDA approval for 1st biosimilar to Amgen's Neulasta

Mylan NV and Biocon Ltd. received the U.S. Food and Drug Administration's approval for the first biosimilar to Amgen Inc.'s blockbuster blood cancer therapy Neulasta.

The biosimilar, Fulphila, is now approved to decrease the chance of infection from febrile neutropenia as a result of chemotherapy in patients with non-myeloid, or non-bone cancer. Biosimilar medicines are deemed by FDA to be highly similar to an already-approved biologic product.

Febrile neutropenia refers to fever, often with other signs of infection, associated with an abnormally low number of infection-fighting white blood cells.

Mylan, whose application for the Neulasta biosimilar was previously rejected by the U.S. FDA, expects to launch Fulphila in the coming weeks.

Under the collaboration with Biocon, Mylan has exclusive commercialization rights for Fulphila in the U.S., Canada, Japan, Australia, New Zealand and in the European Union and European Free Trade Association countries. Biocon has co-exclusive commercialization rights with Mylan for the drug in the rest of the world.

Neulasta brought in $4.2 billion U.S. sales for the year ending March 31, Mylan said, citing data from research firm IQVIA.

Canonsburg, Pa.-based Mylan and India's Biocon have also recently gained U.S. approval for a biosimilar version of Roche Holding AG's cancer drug Herceptin.