To date, only eleven PEGylated proteins, antibody fragments, oligonucleotides, and small molecules that have been…
In November 2015, the Food and Drug Administration approved the use of Amgen’s pegfilgrastim (Neulasta) to increase the survival of people acutely exposed to high-dose radiation that damages the bone marrow, which will improve access to the drug in the event of a public health emergency such as a nuclear power plant accident or terrorist attack. Pegfilgrastim is a pegylated version of filgrastim.
PEGylated Biosimilar Drugs
Pegfilgrastim first received FDA approval in 2002 to reduce the chance of infection due to low white blood cell counts in cancer patients receiving certain types of chemotherapy.
Pegfilgrastim is the second radiation medical countermeasure to be approved under FDA’s Animal Rule, a regulation that permits approval of some products based on efficacy testing in animals and safety testing in humans.