FDA Approves First Biosimilar to Amgen’s Neulasta

FDA announced on June 4, 2018 that it approved Mylan’s Fulphila (pegfilgrastim-jmdb) as the first biosimilar to Amgen’s Neulasta (pegfilgrastim) to reduce the duration of febrile neutropenia (fever or other signs of infection with a low count of neutrophils) in non-myeloid (non-bone marrow) cancer patients treated with myelosuppressive chemotherapy that has a clinically significant incidence of febrile neutropenia. Neulasta had US sales of $4.2 billion for the 12 months ending March 31, 2018, according to IQVIA as cited by Mylan.

Fulphila is the first FDA-approved biosimilar to Neulasta and the second biosimilar from Mylan and Biocon's joint portfolio approved in the United States. The drug minimizes the side effects of chemotherapy treatment, reducing the duration of neutropenia. Mylan expects to launch the drug in the coming weeks.

FDA stated in its press release that Fulphila was approved 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 demonstrates Fulphila is biosimilar to Neulasta. The agency also said that Fulphila has been approved as a biosimilar, not as an interchangeable product.

In July 2016, the European Medicines Agency (EMA) accepted for review Mylan’s marketing authorization application (MAA) for its proposed biosimilar to pegfilgrastim. In August 2017, Mylan withdrew its MAA for the drug, citing that “cGMP clearance of the drug product manufacturing facility was not obtained within current clock-stop.”

Source: FDA, Mylan