Jun 5: Mylan NV and Biocon Ltd on Tuesday announced that the US Food and Drug Administration (USFDA) has approved Mylan’s Fulphila (pegfilgrastim-jmbd), a biosimilar to Neulasta (pegfilgrastim), co-developed with Biocon.
According to a statement from 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’sjoint 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,” the statement said.
Commenting on the development, Mylan President Rajiv Malik said: “today’s approval of Fulphila represents a meaningful step forward in the affordability and accessibility of cancer care in the US. It also is yet another confirmation of Mylan’s deep scientific, clinical, regulatory and intellectual property capabilities, which are widely recognized in the industry and bolster Mylan’s reputation as a partner of choice in the global effort to bring complex medicines to market. The approval of Fulphila, the first biosimilar to Neulasta, joins other recent examples such as the approval of Ogivri, the first biosimilar to Herceptin Q, in the growing portfolio of complex medicines that Mylan is making available for patients who need them. We’re pleased to reach this important milestone in partnership with Biocon and proud of the progress of our biosimilars program.”