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On June 4, the FDA approved the marketing of Mylan Fulphila (pegfilgrastim-jmdb) to reduce the risk of neutropenia infection and fever. Fulphila is the 10th biosimilar approved by the FDA and the first biosimilar of Amgen Neulasta (pegfilgrastim).

 

Amgen launched the world’s first recombinant human granulocyte colony-stimulating factor, Neupogen (filgrastim, filgrastim), in 1991/2/20, which has rapidly been widely accepted in clinical practice. 2002/1/31, Amgen launched Neulasta, the world’s first long-acting G-CSF drug, whose sales were close to the short-acting G-CSF drug Neupogen and became a blockbuster in the second year, and its market share has been rising. 2015 The peak value reached 4.715 billion U.S. dollars. Global sales in 2017 also amounted to 4.534 billion U.S. dollars, which almost monopolized sales of long-lasting G-CSF in the world.

Tumor radiotherapy and chemotherapy usually kills normal cells or causes bone marrow suppression, resulting in a marked decrease in white blood cells and increasing the risk of fever or infection in patients. Pegfilgrastim is a long-acting granulocyte colony-stimulating factor (G-CSF) that binds to specific receptors on the surface of granular progenitor cells or mature neutrophils, and promotes the proliferation and differentiation of progenitor cells of granular systems. And enhance the phagocytosis and killing ability of neutrophils. In addition to adjuvant chemotherapy for tumor chemotherapy, G-CSF is often used for the mobilization of hematopoietic stem cells in bone marrow transplantation and reconstruction of bone marrow hematopoietic function after transplantation, as well as to improve the symptoms of neutrophils caused by myelodysplasia syndrome or myelodysplastic syndrome.

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