Iyeza lebhayoloji liyeza eliqulethe into enye okanye ngaphezulu esebenzayo eyenziwe okanye ekhutshwe kwiiseli eziphilayo okanye kwizinto eziphilayo.
Yintoni iBiosimilar?
Amayeza ebhayoloji ahlala enziwe ngeeproteni ezenziwe ngokwemvelo emzimbeni kwaye ziphuhliselwa ukunyanga uninzi lomhlaza kubandakanya i-lymphoma.
Xa iyeza lebhayoloji lithe lenziwa iyeza lifakwa phantsi kwelungelo elilodwa lomenzi wechiza. Ilungelo elilodwa lomenzi wechiza lilayisensi enika umakhi wokuqala weyeza ilungelo elisemthethweni lokuba abe mnye kuphela emarikeni iminyaka emininzi. Lakuba liphelelwe leli patent ezinye iinkampani zinokuvelisa amayeza afana neyeza lokuqala lebhayoloji kwaye la abizwa ngokuba ngamayeza afanayo ebhayoloji.
Amayeza e-Biosimilar afana neyeza lokuqala kwaye anokusetyenziswa ukunyanga izifo ezifanayo ngendlela efanayo namayeza ebhayoloji. La mayeza afana nebhayoloji avavanyiwe kwaye abonise ukuba akhuselekile kwaye ayasebenza njengamayeza okuqala ebhayoloji.
Ziziphi ii-biosimilars ezisetyenziswa ngoku kwi-lymphoma?
I-Granulocyte colony stimulating factor (G-CSF)
Kukho ngokwangoku amayeza amahlanu afana nebhayoloji avunywe yi-TGA e-Australia ukuba asetyenziswe kwisimo se-lymphoma. Iyeza lokuqala lebhayoloji yifilgrastim elaveliswa yinkampani yoxubo-mayeza i-Amgen yaza yanelungelo elilodwa lomenzi wechiza phantsi kwegama lorhwebo i-Neupogen™. IFilgrastim luhlobo olwenziwe ngumntu lwegranulocyte colony stimulating factor (G-CSF) into eveliswa ngumzimba ukukhuthaza ukukhula kweeneutrophils.
Njengoko i-neutrophils luhlobo lweseli emhlophe yegazi ebalulekileyo kumlo womzimba ngokuchasene nosulelo, i-filgrastim inokunikwa izigulana ezinonyango lwe-lymphoma yazo ukunceda ukuxhasa inani labo le-neutrophil ethotywayo ngonyango abalufumanayo okanye kwiidosi eziphezulu. hlanganisa izigulane ezine-stem cells ukusuka kumongo wethambo ukuya kwi-peripheral blood ukuze ziqokelelwe kumatshini we-apheresis. Lakuba eli yeza lebhayoloji liphumile kwilungelo elilodwa lomenzi wechiza ezinye iinkampani ziye zakwazi ukuvelisa iyeza lebhayoloji efanayo kwaye ngoku kukho iibiosimilars ezintathu zefilgrastim eOstreliya ezinamagama orhwebo athi Nivestim™ aveliswa nguPfizer, iTevagrastim™ eveliswe nguTeva kunye neZarzio™ eveliswe nguSandoz.
Rituximab
I-Rituximab (i-MabThera) yenye ye-antibodies yokuqala eyinkimbinkimbi ye-monoclonal ukuba ne-biosimilar evunyiweyo e-Australia. Ngoku kukho ii-biosimilars ezimbini ze-rituximab e-Australia ngamagama orhwebo i-Riximyo eveliswe ngu-Sandoz kunye ne-Truxima eveliswe yi-Celltrion.
Zivavanywa kwaye zamkelwe njani?
I-biosimilar idlula kuvavanyo olubanzi kwilabhoratri nakwizilingo ezincinci zeklinikhi ukuyithelekisa neyeza lokuqala. Kufuneka ihambelane kumgangatho, ukhuseleko, kunye nokusebenza kakuhle (ukusebenza kakuhle kangakanani).
Emva koko uvavanyo olukhulu lweklinikhi lwenziwa kwiqela labantu abanesifo esisetyenziswe okokuqala. Oku kukuqinisekisa ukuba ukhuseleko kunye nokusebenza ngokufanelekileyo kuhambelana noqobo.
I-biosimilar akunyanzelekanga ukuba ivavanywe kuso sonke isifo esivunyiweyo esokuqala. Olu vavanyo lwenziwa ngeyeza lokuqala ngoko sele kukho ubungqina bokuba iyeza liyasebenza kwezo zifo. Ukuba i-biosimilar isebenza kakuhle kwi-1 kubo, akukho sizathu esingayi kuziphatha ngendlela efanayo kwabanye.
Kutheni ziphuhliswa nje?
Ukufumaneka kwee-biosimilars kwandisa ukhuphiswano. Ukhuphiswano kufuneka lwehlise iindleko. Ukukopa iyeza eliphumelelayo kukhawuleza kakhulu kunokuphuhlisa iyeza elitsha. Ulingo lwezonyango olumbalwa luyafuneka ukuba ngaba sele kusaziwa ukuba yeyiphi izifo elisebenza kuzo iyeza. Ii-Biosimilars zihlala zitshiphu kakhulu kuneyeza lokuqala nangona umgangatho wamayeza ufana.
Imibuzo ebuzwa qho
Amayeza e-Biosimilar angasetyenziswa nokuba ngaba uye waphathwa okokuqala nge-Biologic.
Isibhedlele sakho sinokutshintsha iibrendi ze-rituximab njengoko ii-biosimilars zifumaneka. Ii-biosimilars ze-Rituximab zinikwa kuphela nge-intravenously (ngokuthontsiza kwi-vein). Ukuba sele une-rituximab emithanjeni, isibhedlele sakho sinokufuna ukuba utshintshe iibrendi ukuba kuyimfuneko. Basenokutshintsha ukuba abanalo uphawu lwakho lwangoku kwisitokhwe. Ugqirha wakho okanye usokhemesti unokuphendula nayiphi na imibuzo onokuba nayo malunga nokutshintsha iibrendi.
Inye kuphela ibhrendi ye-rituximab engaphantsi kwesikhumba (enikwe ngesitofu phantsi kwesikhumba) ekhoyo ngoku. Ukuba une-rituximab engaphantsi kwesikhumba (ngenaliti phantsi kwesikhumba), kunokwenzeka ukuba uqhubeke nale nto kwikhosi yakho yonyango.
Thetha nogqirha okanye umongikazi okunika unyango. Baza kukwazi ukuphendula nayiphi na imibuzo onokuba nayo malunga nokutshintsha iibrendi.
Ii-biosimilars zohlukile kumayeza enziwe afana nalawo aveliswe ngabenzi njengoko amayeza enziwe afana nalawo enziwe ngabenzi bawo eyinto enye esebenzayo njengeyeza lokuqala lekhemikhali. Umzekelo weyeza elenziwe afana nalawo aveliswe ngumenzi liyeza lokuqala lekhemikhali iparacetamol eyayinelungelo elilodwa lomenzi wePanadol™ kwaye amayeza enziwe afana nalawo aveliswe ngumenzi abandakanya iPanamax™ kunye neHerron™ njengemizekelo.
