FDA approves Fulphila for non-bone marrow cancer patients undergoing bone marrow-inhibited chemotherapy
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Last Update: 2020-06-11
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Source: Internet
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Author: User
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recently, the U.SFDA(approved Fulphila (pegfilgrastim-jmdb) for use in non-bone marrow cancer patients undergoing bone marrow inhibition chemotherapy to reduce the incidence of febrile neutropenia, FNFulphilaFulphila is Neulasta's first biosimilar (Biosimilar), developed by(co-developed) by Mylan and Bioconin late 2017, Mylan's Ogivri was approved by the FDA as the first biosimilar to HerceptinNeulasta was approved by the FDA as early as 2002 as a prescription drug for non-bone marrow cancer patients undergoing chemotherapy who had a higher risk of infection due to low white blood cell countsNeulasta is called a white blood cell promoter, which is an artificial granulocytic set-off stimulator (G-CSF) that stimulates the growth of neutrophils and helps the body produce more anti-infective white blood cells during chemotherapy, thus helping patients fight infectiondata show that Fulphila is(the drug is highly similar) to the FDA-approved patentof the original research and research, and there are no clinical differences in safety, purity, and efficacyFda approval of Fulphila is based on a wide range of structural and functional characterizations, animal research data, human pharmacokinetics and pharmacodynamicdata, clinical immunoogenic data, and other data, demonstrating that Fulphila is a biosimilar to Neulasta with similar clinical safety and efficacy dataFulphila was approved as a biosimilar drug, rather than athat replacesproducts, which require more additional requirements and can replace the use of patented drugs
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