%0 Journal Article
%T monoclonalantibody:thecornerstoneofmodernbiotherapeutics
%A xia
%A zhi-nan*
%A cai
%A xue-ting
%A cao
%A peng
%J ҩѧѧ±¨
%P 1275-1280
%D 2012
%X 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.
%U http://www.yxxb.com.cn:8081/aps/CN/abstract/abstract14313.shtml