US approval for Mylan and Biocon’s Neulasta biosimilar

Arikayce first therapy approved in US for MAC patients
Credit: Castleski

Mylan has gained approval from regulators in the US for Fulphila, the first biosimilar to Neulasta, which it 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 US.

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.