Njengoba ama-biosimilars eba mncane womqondo futhi okungokoqobo e-United States, iziguli ezinezifo zesifo sofuba (IBD) ziyoba nemibuzo eminingi ngalezi zidakamizwa. Ama-biosimilars yizidakamizwa ze-biologic, kodwa azifani nezithiyo ze-biologic. Lokhu kuvula imibuzo eminingi - kokubili odokotela neziguli - ngokuthi indlela i-biosimilar ingasetshenziswa ngayo ukuphatha i-IBD.
Nakuba izidakamizwa ze-biologic zisetshenziselwa ukwelapha izimo ngaphandle kwe-IBD, ukuhumusha imiphumela kusuka ocwaningweni olwenziwe ngeziguli ngaphandle kwe-IBD kuyinkinga. Lokhu kungenxa yokuthi iziguli ze-IBD zinamazinga ahlukene alezi zidakamizwa emzimbeni wazo kunabantu abangenayo i-IBD. Ngakho-ke, kungase kube yisikhathi esithile ngaphambi kokuba sibe nedatha enhle kusuka ekuhloleni okusekelwe kahle ekliniki ngezidakamizwa ze-biosimilar kubantu abane-IBD.
Asinayo izimpendulo zemibuzo eminingi, kodwa singasebenzisa lokho esikwaziyo kakade futhi size nezinye izinkolelo. Nakhu esikwaziyo manje mayelana nokuthi iziguli zingalindela kuphi eziphilayo.
Izidakamizwa ze-Biologic
Imithi ye-biologic imithi esetshenziselwa ukwelapha izifo nemibandela, futhi ku-IBD, ngezinye izikhathi isetshenziselwa ukunciphisa noma ukuyeka ukuvuvukala emzimbeni. Imithi ye-biologic evunyelwe ukuphatha i-IBD ihlanganisa iHuma (adalimumab) , iCimzia (certolizumab pegol) , i- Remicade (infliximab) , i-Tysabri (natalizumab), i- Simponi (golimumab) , ne- Entyvio (i-vedolizumab) .
Uma isiguli "siphumelela" i-Biologic, Ingabe i-Biosimilar iyindlela?
Njengoba sazi, wonke umuntu onenhlangano ye-IBD uphendula imithi ngokuhlukile. Abanye abantu abane-Crohn's disease noma i-ulcerative colitis bangase bangaphenduli kumuthi we-biologic noma bangase bangabekezeleki ngokuhamba kwesikhathi. Ukuvuvukala noma izimpawu akungathinti izidakamizwa noma bangase baqale ukubuya naphezu kokusetshenziswa kwezidakamizwa.
Uma kwenzeka lokhu kuvame ukubizwa ngokuthi "ukwehluleka" kwesidakamizwa. Lokhu akukhona ukwehluleka kwengxenye yesiguli noma udokotela noma izidakamizwa, kodwa leli yigama elisetshenzisiwe. Okushiwo ukuthi umuthi awuzange usebenze ngokuvuvukala ku-IBD, futhi uma ungasebenzi, kusobala ukuthi uyeka ukuzama. Odokotela bangase babhekisele ezinkingeni ezihlukene ngokuthi ukwehluleka "okuyisisekelo" noma "kokubili", kuye ngokuthi ngabe lesi sidakamizwa asizange sisebenze nhlobo, noma ngabe sasebenza okwesikhashana bese simisa.
Uma isiguli singaphenduli igama le-brand biologic, kufanele ukhethe ukuthi imiphi imithi yokuzama ukulandela. Ukuzama isidakamizwa esiyi-biosimilar yegama-brand biologic, noma kunjalo, kucatshangwa ukuthi akuyona inketho. Uma, njengesibonelo, isiguli singelahleki (noma sinomthelela omubi) ku-biologic ethile, isiguli cishe sizoba nomthelela emzimbeni we-biosimilar. Futhi, ngenkathi i-biosimilar ingeke ibe yincwajana ecacile yegama-brand biologic, okwamanje kucatshangwa ukuthi isiguli esingaphenduli komunye cishe ngeke siphendule komunye. Ngakho-ke, kucatshangwa ukuthi i-biosimilar ngeke inikeze enye inketho yokwelapha isiguli esivele sehlulekile i-biologic (kanye ne-vice-versa).
Ukushintshanisa Phakathi Kwezinto Eziphilayo Nezici
Kunokukhathazeka ukuthi iziguli zingashintsha phakathi kwe-biologic kanye ne-biosimilar ngaphandle kolwazi noma imvume yabo. Lokhu ngezinye izikhathi kwenzeka ngezidakamizwa ezijwayelekile : udokotela angase anikeze igama lomkhiqizo, kodwa inkampani yomshuwalense ifuna imali yokulondoloza izindleko, ngakho-ke izidakamizwa zishintsha ku-generic.
Endabeni ye-biologic, ngalesi sikhathi, aziwa ukuthi kuzokwenzekani uma isiguli esenza kahle kumuthi othile we-biologic sishintsha kumuthi we-biosimilar. Akukho bufakazi bokuthi wenze iziphetho mayelana nalesi simo okwamanje. Kodwa-ke, kucatshangwa ukuthi ngoba i-biosimilar ne-biologic ayifani ngokufanayo, ngeke neze iguquke ngale ndlela.
Ochwepheshe basikisela ukuthi uma isiguli senza kahle, kufanele siqhubeke sithola izidakamizwa abaye bahlala kuzo, kungakhathaliseki ukuthi yilo bi-brand-brand noma yi-biosimilar.
Eminye imibuso idlulisele umthetho ngokuphathelene nama-biosimilars, kanti abanye banemithetho elindelwe, kodwa akuzona zonke izifunda ezikucabangayo. Ezimweni eziningi, lo mthetho uhlanganisa ulimi olwenza kucacise ukuthi kuphela umuthi oqondile owenziwe udokotela (noma i-biologic noma i-biosimilar), futhi izakhiwo ezivunyelweyo zivunyelwe kuphela uma udokotela kanye nesiguli bevuma.
Ukukhathazeka kweziguli ze-IBD ukuthi izinkampani zomshuwalense zingase zicindezele iziguli ukuba zishintshe imishanguzo uma i-biosimilar ingabizi kakhulu, ngisho noma i-biologic iye yaphumelela kuze kube manje. Ngokuphathelene nokushintsha phakathi kwezinto eziphilayo nezidakamizwa, uDkt. Scott Plevy, uMholi Wezinkinga Zesifo Sengculaza, Isifo Sokukhubazeka E-Janssen Research & Development sathi (ukukhulumisana ngomlomo, ngoFebruwari 2016) "awudli kahle ngalezi zifo."
Ingabe Kukhona Indawo Yabachwepheshe?
Nakuba ukushintsha phakathi kwe-biologic ne-biosimilar akubhekwa njengendlela ephumelelayo yokuphatha i-IBD kuleli phuzu, empeleni ukuqala ukwelapha nge-biosimilar kungaba yindlela yokukhetha iziguli ezithile. Lokhu kunikeza enye indlela yokwelashwa, okuyinto izindaba ezinhle ezigulini. Ukwenza ushintsho kusuka ku-biosimilar kuya ku-biologic kungahle kube yinkinga, ngakho-ke lokho akucatshangwanga ukuthi kuyindlela yokukhetha. Uma isiguli senza kahle nge-biosimilar, kucatshangwa ukuthi isidakamizwa esifanayo kufanele siqhutshwe, kufana nesimo esiqondayo.
I-Price of Biosimilars
Ngalesi sikhathi, ukuthi izindleko zizophuma kanjani emakethe akukaziwa. Abaningi babikezela ukuthi ama-biosimilars ayobiza kancane kunezinto eziphilayo. Noma kunjalo, lokhu akusona isiqinisekiso, futhi kukhona okungenzeka inkampani eyenza i-biosimilar ukukhokhisa intengo efana neyakhokhiswa umenzi we-biologic. Ngenxa yokuthi izinqubomgomo zomshuwalense ziyahlukahluka, isimo sizobe sisekelwe ekuhloleni ngabanye futhi noma ngabe inkampani yezokwelapha ephethe i-patent emzimbeni we-biologic inikeza ukulinganisa kwamanani noma enye indlela yokunciphisa izindleko, njengendlela yokusiza isiguli. Kunezinhlobo eziningi eziningi ezihilelekile kumanani entengo, kunzima ukubikezela. Kucatshangwa ukuthi amanani angase abe nokuncintisana okuphelele, kokubili biosimilars kanye biologics, okuyinto kuyoba inzuzo enkulu iziguli.
Okubalulekile
Indlela yokukhetha yokwelapha yeziguli ze-IBD e-US ishintsha. Ukwamukelwa kwemithi ye-biosimilar kuveza imibuzo eminingi mayelana nokusetshenziswa kwabo okungaphendulwa kuphela ngokuhamba kwesikhathi. Kukhona idatha encane yokuqhubeka kuze kube manje ngemithi ye-biosimilar, kodwa ochwepheshe bezempilo baye benza ukuqagela okufundisiwe ukuthi bangasetshenziswa kangcono kuziguli ezine-IBD nezinye izimo. Kuyoba khona izifundo eziningi nemithetho neziqondiso ezibekiwe ezinyangeni ezizayo, kodwa, njengoba njalo, i-gastroenterologist yakho izoba umthombo ongcono kakhulu wolwazi mayelana nezinketho zakho zokwelashwa.
Imithombo:
Ukuphathwa kwe-US nokuDrug. "Ulwazi oluphathelene nama-Biosimilars." FDA.gov. 22 Feb 2016.