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药学学报 2012
monoclonalantibody:thecornerstoneofmodernbiotherapeutics, PP. 1275-1280 Abstract: worldwidesalesofbiologicdrugsexceeded100billionusdin2011.？about32%isfromtherapeuticmonoclonalantibody(mab).？withmanyblockbusterbiopharmaceuticalpatentsexpiringoverthenextdecade,thereisagreatopportunityforbiosimilartoentertheworldwideespeciallyemergingmarket.？botheuropeanmedicinesagency(ema)andfoodanddrugadministration(fda)haveintroducedregulatoryframeworksforthepotentialapprovalofbiosimilarmabtherapeutics.？ratherthanprovidingahighlyabbreviatedpath,asinthecaseforsmallmoleculechemicaldrug,approvalforbiosimilarmabwillrequireclinicaltrialandthedetailswillbeverymuchonacase-by-casebasis.？sincemabisthedominantcategoryofbiologicdrugs,mabwillbethefocusofthisreview.？first,theunitedstates(us)andeuropeanunion(eu)approvedmabandthoseinphase3trialswillbereviewed,thenstrategiesonhowtowinbiosimilarcompetitionwillbereviewed.
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