FDA Okays Mylan And Biocon's Fulphila, First Biosimilar To Neulasta

(RTTNews) - Mylan N.V. (MYL) and Biocon Ltd. said that the U.S. Food and Drug Administration has approved Mylan's Fulphila or pegfilgrastim-jmbd, a biosimilar to Neulasta or pegfilgrastim, co-developed with Biocon. Fulphila has been approved to reduce the duration of febrile neutropenia--fever or other signs of infection with a low count of neutrophils, a type of white blood cells-- in patients treated with chemotherapy in certain types of cancer.

Fulphila is the first FDA-approved biosimilar to Neulasta and the second biosimilar from Mylan and Biocon's joint portfolio approved in the U.S. Mylan anticipates launching Fulphila in the coming weeks, representing the first alternative, more affordable treatment option to Neulasta for oncology patients. A suite of patient services also will be available at launch to further support patients and caregivers with treatment.

Neulasta had U.S. sales of $4.2 billion for the 12 months ending March 31, 2018, according to IQVIA.

Fulphila is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.