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# Mylan’s Neulasta Biosimilar Approved by FDA
- URL: https://www.fdaweb.com/mylans-neulasta-biosimilar-approved-by-fda/
- Published: 2018-06-04T12:00:00.000Z
- Updated: 2026-09-15T00:10:14.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141599

FDA has approved Mylan’s Fulphila (pegfilgrastim-jmdb) as the first biosimilar to Amgen’s Neulasta (pegfilgrastim) to decrease the chance of infection as suggested by febrile neutropenia (fever, often with other signs of infection, associated with an abnormally low number of infection-fighting white blood cells), in patients with non-myeloid (non-bone marrow) cancer who are receiving myelosuppressive chemotherapy that has a clinically significant incidence of febrile neutropenia. Approval is based on a review of evidence that included extensive structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamic data, clinical immunogenicity data, and other clinical safety and effectiveness data that demonstrate Fulphila is biosimilar to Neulasta.

In [announcing](https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm609805.htm?ref=fdaweb.com) the approval, FDA commissioner **Scott Gottlieb** said that this summer the agency will “release a comprehensive new plan to advance new policy efforts that promote biosimilar product development. Biologics represent some of the most clinically important, but also costliest products that patients use to promote their health. We want to make sure that the pathway for developing biosimilar versions of approved biologics is efficient and effective, so that patients benefit from competition to existing biologics once lawful intellectual property has lapsed on these products.”