Earlier this month, the U.S. FDA announced approval of Mylan’s Fulphila biosimilar to Neulasta® (pegfilgrastim).  Neulasta® was developed by Amgen and first approved in the U.S. and Europe in 2002.  Following the approval announced on June 4, 2018, Fulphila, which was co-developed with Biocon, becomes the first biosimilar to pegfilgrastim approved in the U.S.

The FDA approved Fulphila to treat cancer patients with non-myeloid cancers receiving myelosuppressive chemotherapy that have clinically significant incidence of febrile neutropenia.  As we reported previously, Neulasta® (pegfilgrastim) biosimilars have failed to gain approval in Europe and in the United States despite numerous attempts.  The FDA previously rejected several pegfilgrastim applications, including the first Biologics License Application filed by Mylan/Biocon, and there are currently eight applications for pegfilgrastim pending in Europe.

Nevertheless, the FDA explained in their announcement that the review of evidence showed “extensive structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamic data, clinical immunogenicity data, and other clinical safety and effectiveness data that demonstrates Fulphila is biosimilar to Neulasta.”  The announcement marks another major win for Mylan and Biocon following the December 2017 approval of their co-developed Ogivri biosimilar to Herceptin® (traztuzumab).

The patents covering Neulasta® expired in October 2015 in the U.S. and August 2017 in Europe.  Mylan and Biocon also submitted an application for their pegfilgrastim candidate biosimilar product (MYL-1401H) to the European Medicines Agency (EMA).  However, Europe has yet to approve a pegfilgrastim biosimilar.

The FDA Commissioner, Scott Gottlieb, stressed that the U.S. agency will continue to prioritize review of biosimilar products.  As a result, the U.S. may start to gain some ground on the European markets, which have seen biosimilar approvals rapidly increase over the last three years. Click here to learn more about how the U.S. compares to Europe in biosimilars approvals and products in the pipeline.