Society and culture Filgrastim

1 society , culture

1.1 production
1.2 commercialization
1.3 biosimilar

society , culture
production

it produced recombinant dna technology. gene human granulocyte colony-stimulating factor inserted genetic material of escherichia coli. g-csf produced e. coli different g-csf naturally made in humans.

commercialization

filgrastim marketed under several brand names, including:

apricus biosciences developing , testing product under brand name nupen can deliver filgrastim through skin improve post-chemotherapy recovery of neutrophil counts.

biosimilar

in 2015, sandoz’s filgrastim-sndz (trade name zarxio), obtained fda s approval biosimilar. first product passed under biologics price competition , innovation act of 2009 (bpci act), part of president obama s march 2010 affordable care act. zarxio approved biosimilar, not interchangeable product, fda notes. , under bpci act, biologic has been approved “interchangeable” may substituted reference product without intervention of health care provider prescribed reference product. fda said approval of zarxio based on review of evidence included structural , functional characterization, animal study data, human pharmacokinetic , pharmacodynamics data, clinical immunogenicity data , other clinical safety , effectiveness data demonstrates zarxio biosimilar neupogen.

zarxio approved same indications neupogen, , can prescribed health care professional for: patients cancer receiving myelosuppressive chemotherapy; patients acute myeloid leukemia receiving induction or consolidation chemotherapy; patients cancer undergoing bone marrow transplantation; patients undergoing autologous peripheral blood progenitor cell collection , therapy; , patients severe chronic neutropenia.