Umuthi webhayoloji umuthi oqukethe into eyodwa noma ngaphezulu esebenzayo eyenziwe noma ekhishwe kumaseli aphilayo noma izinto eziphilayo.
Iyini i-Biosimilar?
Imithi yebhayoloji ivamise ukwakhiwa ngamaprotheni enziwe ngokwemvelo emzimbeni futhi athuthukiswa ukwelapha imidlavuza eminingi kuhlanganise ne-lymphoma.
Uma umuthi webhayoloji usukhiqiziwe umuthi ufakwa ngaphansi kwelungelo lobunikazi. Ilungelo lobunikazi ilayisense enikeza umthuthukisi wangempela womuthi ilungelo elingokomthetho lokuba munye kuphela emakethe iminyaka embalwa. Uma leli lungelo lobunikazi seliphelelwe yisikhathi ezinye izinkampani zingakhiqiza imithi efana nemithi yokuqala yebhayoloji futhi lena ibizwa ngokuthi imithi efana ne-biosimilar.
Imithi ye-Biosimilar ifana nemithi yokuqala futhi ingasetshenziswa ukwelapha izifo ezifanayo ngendlela efanayo nemithi yebhayoloji. Le mithi efana ne-biosimilar ihloliwe futhi ibonise ukuthi iphephile futhi isebenza njengemithi yokuqala yebhayoloji.
Imaphi ama-biosimilars asetshenziswa njengamanje ku-lymphoma?
I-Granulocyte colony stimulating factor (G-CSF)
Njengamanje kunemithi emihlanu efana ne-biosimilar egunyazwe yi-TGA e-Australia ukuze isetshenziswe esimweni se-lymphoma. Umuthi wokuqala webhayoloji yi-filgrastim eyakhiqizwa inkampani eyenza imithi i-Amgen futhi yaba nelungelo lobunikazi ngaphansi kwegama lokuhweba elithi Neupogen™. I-Filgrastim iwuhlobo olwenziwa umuntu lwe-granulocyte colony stimulating factor (G-CSF) okuyinto ekhiqizwa umzimba ukuze ikhuthaze ukukhula kwama-neutrophils.
Njengoba ama-neutrophils ewuhlobo lwamangqamuzana amhlophe egazi abalulekile ekulweni komzimba nokutheleleka, i-filgrastim inganikezwa iziguli ezelashelwa i-lymphoma yazo ukuze isize ukusekela isibalo sazo sama-neutrophil esehliswa ngokwelashwa ezikutholayo noma ngemithamo ephezulu hlanganisa ama-stem cell eziguli ukusuka kumnkantsha ukuya egazini le-peripheral ukuze aqoqwe emshinini we-apheresis. Lapho lo muthi webhayoloji usuphumile kulungelo lobunikazi ezinye izinkampani sezikwazile ukukhiqiza umuthi we-biosimilar futhi njengamanje kunezinhlobo ezintathu ze-biosimilars ze-filgrastim e-Australia ezinamagama okuhweba i-Nivestim™ akhiqizwe u-Pfizer, i-Tevagrastim™ ekhiqizwe ngu-Teva kanye ne-Zarzio™ ekhiqizwe ngu-Sandoz.
I-Rituximab
I-Rituximab (i-MabThera) ingelinye lamasosha omzimba okuqala ayinkimbinkimbi e-monoclonal ukuba ne-biosimilar evunyelwe e-Australia. Njengamanje kunama-biosimilars amabili e-rituximab e-Australia namagama okuhweba i-Riximyo akhiqizwe ngu-Sandoz kanye ne-Truxima ekhiqizwe yi-Celltrion.
Baquliswa kanjani futhi bagunyazwe kanjani?
I-biosimilar idlula ekuhlolweni okubanzi elabhorethri nasezivivinyweni ezincane zomtholampilo ukuze iqhathaniswe nomuthi wokuqala. Kufanele ifane ngekhwalithi, ukuphepha, nokusebenza kahle (ukuthi isebenza kahle kanjani).
Bese kwenziwa uhlolo olukhulu lomtholampilo eqenjini labantu abanesifo esisetshenziselwe sona sokuqala. Lokhu okokuqinisekisa ukuthi ukuphepha nokusebenza kufana nokwasekuqaleni.
I-biosimilar akudingeki ukuthi ihlolwe kuzo zonke izifo ezigunyazwe okokuqala. Lezi zivivinyo zenziwa ngomuthi wokuqala ngakho sekunobufakazi bokuthi umuthi uyasebenza kulezo zifo. Uma i-biosimilar isebenza kahle ku-1 yazo, asikho isizathu sokuthi ingaziphathi ngendlela efanayo kwabanye.
Kungani zithuthukiswa?
Ukutholakala kwama-biosimilars kukhulisa ukuncintisana. Ukuncintisana kufanele kwehlise izindleko. Ukukopisha umuthi ophumelelayo kuyashesha kakhulu kunokwakha umuthi omusha. Kudingeka izivivinyo zomtholampilo ezimbalwa uma kwaziwa kakade ukuthi yiziphi izifo umuthi osebenza kuzo. Ama-Biosimilars ngokuvamile ashibhe kakhulu kunomuthi wokuqala nakuba ikhwalithi yemithi ifana.
Imibuzo ejwayelekile ukubuzwa
Imithi ye-Biosimilar ingasetshenziswa noma ngabe uke welashwa kuqala nge-Biologic.
Isibhedlela sakho singase sishintshe izinhlobo ze-rituximab njengoba ama-biosimilars etholakala. Ama-biosimilars e-Rituximab anikezwa kuphela nge-intravenously (ngokungena emithanjeni). Uma usuvele une-rituximab emthanjeni, isibhedlela sakho singase sifune ukuthi ushintshe amabhrendi uma kudingeka. Angase ashintshe uma bengenalo uhlobo lwakho lwamanje esitokweni. Udokotela wakho noma usokhemisi angaphendula noma yimiphi imibuzo ongase ube nayo mayelana nokushintsha imikhiqizo.
Uhlobo olulodwa kuphela lwe-rituximab engaphansi (enikezwa ngomjovo ngaphansi kwesikhumba) olutholakalayo okwamanje. Uma une-rituximab engaphansi kwesikhumba (ngokujova ngaphansi kwesikhumba), kungenzeka ukuthi uqhubeke nalokhu ngesikhathi sakho sokwelashwa.
Khuluma nodokotela noma unesi okunikeza ukwelashwa. Bazokwazi ukuphendula noma yimiphi imibuzo ongase ube nayo mayelana nokushintsha amabhrendi.
Ama-Biosimilars ahlukile emithini ejwayelekile njengoba imithi ejwayelekile iyisithako esisebenzayo esifanayo nesomuthi wokuqala wamakhemikhali. Isibonelo somuthi ojwayelekile umuthi wokuqala wekhemikhali i-paracetamol owawunelungelo lobunikazi njengePanadol™ kanti imithi ejwayelekile ihlanganisa iPanamax™ kanye neHerron™ njengezibonelo.
