FDA Approves Mylan’s Neulasta Biosimilar

The FDA approved Mylan’s Fulphila (pegfilgrastim-jmdb) as the first biosimilar to Neulasta for reducing the chance of infection caused by febrile neutropenia in patients with non-bone marrow cancer.

The medication is meant for patients who are receiving myelosuppressive chemotherapy that has a clinically significant incidence of febrile neutropenia.

The agency cautioned that patients should not take Fulphila if they have a history of allergic reactions to human granulocyte colony-stimulating factors like pegfilgrastim or filgrastim products.