Pokhala ndi akatswiri a zamoyo osakhala ndi lingaliro laling'ono ndi zowona ku United States, odwala omwe ali ndi matenda opatsirana (IBD) adzakhala ndi mafunso ambiri okhudza mankhwalawa. Akatswiri a mankhwalawa ndi mankhwala osokoneza bongo, koma si ofanana ndi mankhwala otchedwa biologic mankhwala. Izi zikutsegula mafunso ambiri - kwa madokotala ndi odwala - momwe biosimilar ingagwiritsidwe ntchito pochiza IBD.
Ngakhale mankhwala osokoneza bongo amagwiritsidwa ntchito pochita zinthu zina osati IBD, kutanthauzira zotsatira kuchokera ku phunziro lomwe laperekedwa kwa odwala popanda IBD ndilovuta. Izi ndi chifukwa chakuti odwala IBD ali ndi mankhwala osiyanasiyana m'mitembo yawo kuposa anthu omwe alibe IBD. Choncho, pangakhale nthawi yambiri tisanakhale ndi deta yabwino kuchokera kuzipatala zokonzedwa bwino zomwe zili ndi mankhwala osokoneza bongo kwa anthu omwe ali ndi IBD.
Sitili ndi mayankho a mafunso ambiri, koma tikhoza kugwiritsa ntchito zomwe tikudziwa kale ndikubwera ndi ziphunzitso zina. Pano pali zomwe tikudziwa panopa zomwe odwala angayembekezere kuchokera ku zamoyo.
Mankhwala Osokoneza Bongo
Mankhwalawa ndi mankhwala omwe amagwiritsidwa ntchito pochizira matenda, komanso mu IBD, nthawi zina amagwiritsidwa ntchito kuchepetsa kapena kusiya kutupa thupi. Mankhwala omwe amavomerezedwa ndi mankhwalawa ndi Huma (adalimumab) , Cimzia (certolizumab pegol) , Remicade (infliximab) , Tysabri (natalizumab), Simponi (golimumab) , ndi Entyvio (vedolizumab) .
Ngati Wodwala "Akulephera" Biologic, Kodi Biosimilar Ndi Njira?
Monga tikudziwira, aliyense yemwe ali ndi IBD amayankha mankhwala mosiyana. Anthu ena omwe ali ndi matenda a Crohn's or ulcerative colitis sangasangalale ndi mankhwala osokoneza bongo kapena akhoza kukhala osasamala nawo pakapita nthawi. Kutupa kapena zizindikiro sizimakhudzidwa ndi mankhwalawa kapena akhoza kuyamba kubwerera ngakhale kugwiritsa ntchito mankhwala.
Izi zikachitika nthawi zambiri zimatchedwa "kulephera" mankhwala. Izi siziri zolephera pa gawo la wodwala kapena dokotala kapena mankhwala, koma iyi ndigwiritsidwe ntchito. Izi zikutanthauza kuti mankhwalawa sanagwire ntchito yotupa kuchokera ku IBD, ndipo ngati sakugwira ntchito, mwachiwonekere mukusiya kuyesera. Madokotala angathenso kutchula zosiyana ndi zovuta monga "choyamba" kapena "chachiwiri" kulephera, malingana ndi kuti mankhwalawa sanagwiritsepo ntchito konse, kapena ngati atagwira ntchito kwa nthawi ndikuimitsa.
Pamene wodwala sakuyankha dzina lake-biologic, chisankho chiyenera kupangidwa ndi mankhwala omwe amayesa kutsatira. Kuyesera mankhwala omwe ali biosimilar a dzina-brand biologic, komabe, akuganiza kuti sangachite. Ngati, mwachitsanzo, wodwalayo ali ndi vuto (kapena ali ndi vuto linalake) kwa biologic, wodwalayo akhoza kukhala osayanjanitsidwa ndi biosimilar. Ndipo, pamene biosimilar sidzakhala yeniyeni yeniyeni ya dzina-brand biologic, pakalipano amaganiza kuti wodwala amene sakuyankhapo mwina sangayankhe wina. Choncho, zikuganiziridwa kuti biosimilar sichidzaperekanso chithandizo chamankhwala kwa wodwalayo amene walephera kale biologic (ndi mosemphana ndi malamulo).
Kusintha Pakati pa Zamoyo ndi Zosayansi
Pali nkhawa kuti odwala akhoza kusintha pakati pa biologic ndi biosimilar popanda kudziwa kapena kuvomereza. Izi nthawi zina zimachitika ndi mankhwala ochiritsira : dokotala angapereke dzina lake, koma kampani ya inshuwalansi ikufunafuna ndalama, kotero mankhwalawo amasintha kwachibadwa.
Pankhani ya biologic, pakadali pano, sizikudziwika chomwe chidzachitike ngati wodwala amene akuchita bwino pa mankhwala enaake a biologic amasinthidwa ku mankhwala osokoneza bongo. Palibe umboni uliwonse wotsimikizira za zochitika izi. Komabe, akuganiza kuti chifukwa biosimilar ndi biologic siziri chimodzimodzi, sizidzasinthika motere.
Akatswiri amanena kuti ngati wodwalayo akuchita bwino, apitirize kulandira mankhwala omwe akhalapo, kaya dzina lake ndi biologic kapena ndi biosimilar.
Maiko ena adapereka malamulo pazinthu zamoyo, ndipo ena ali ndi lamulo likuyembekezereka, koma sikuti dziko lililonse likulingalira. Nthawi zambiri, malamulowa amaphatikizapo chilankhulo chomwe chimawonekeratu kuti mankhwala enieni omwe adalangizidwa ndi dokotala (kapena biologic kapena biosimilar) ayenera kugwiritsidwa ntchito, ndipo mmalo mwake amaloledwa ngati dokotala komanso wodwala akugwirizana.
Kuda nkhawa kwa akudwala a IBD ndi kuti makampani a inshuwalansi angakakamize odwala kuti asinthe mankhwala ngati biosimilar ilibe mtengo, ngakhale biologic ikadali yothandiza. Ponena za kusinthasintha pakati pa zamoyo ndi zamoyo, Dr. Scott Plevy, Mtsogoleri Wachilengedwe Wachilombo, Matenda Opatsirana Opatsirana pa Janssen Research & Development adati (kulankhulana momveka bwino, February 2016) "Simunasokoneze ndi matendawa."
Kodi Pali Malo Othandizira Ambiri?
Pamene kusinthasintha pakati pa biologic ndi biosimilar sikunali njira yabwino yothandizira IBD panthawiyi, makamaka kuyamba mankhwala ndi biosimilar kungakhale mwayi kwa odwala ena. Izi zimapereka chithandizo chamankhwala ena, omwe ndi uthenga wabwino kwa odwala. Kupanga kusintha kuchokera ku biosimilar kupita ku biologic kungakhalebe vuto, kotero sichimaganiziridwa kuti ndizosankha. Ngati wodwalayo akuchita bwino, akuganiza kuti mankhwala omwewo ayenera kupitilizidwa, mofanana ndi momwe zinthu zilili.
Mtengo wa Ophunzira
Panthawiyi, momwe ndalamazo zidzakhalire pamsika sizidziwikabe. Ambiri akulosera kuti zamoyo zidzakhala zochepa kuposa biologics. Komabe, ichi si chitsimikiziro, ndipo pali kampani yomwe imapangitsa biosimilar kuti azilipiritsa mtengo wofanana ndi umene unaperekedwa ndi wopanga biologic. Chifukwa chakuti inshuwalansi ndi yosiyana, izi zidzakhazikitsidwa payekha komanso ngati kampani ya mankhwala yomwe ili ndi chidziwitso cha mankhwala osokoneza bongo ikupereka kuyeza mtengo kapena njira yowonjezera mtengo, monga pulogalamu yothandizira odwala. Pali mitundu yambiri yomwe ikukhudzidwa ndi mitengo yamtengo wapatali, ndi zovuta kufotokozera. Zimaganiziridwa kuti mitengo ingakhale yopikisano yowonjezera, kwa zamoyo zonse ndi biologics, zomwe zidzakhala zopindulitsa kwambiri kwa odwala.
Mfundo Yofunika Kwambiri
Momwe mungasankhire mankhwala omwe akudwala a IBD ku US akusintha. Chivomerezo cha mankhwala osokoneza bongo akubweretsa mafunso ambiri ponena za kugwiritsa ntchito komwe kungayankhidwe kanthawi. Pali deta yochepa yomwe mungapite nayo mpaka pano ndi mankhwala osokoneza bongo, komabe akatswiri a zachipatala apanga zodziŵika bwino momwe angagwiritsire ntchito bwino odwala omwe ali ndi IBD ndi zina. Padzakhala maphunziro ochuluka ndi malamulo ndi ndondomeko zomwe zidzakhazikitsidwe mu miyezi ikubwera, koma, monga nthawi zonse, gastroenterologist wanu adzakhala gwero labwino la chidziwitso chokhudza momwe mungasankhire mankhwala.
Zotsatira:
US Food and Drug Administration. "Chidziwitso kwa akatswiri a zamoyo." FDA.gov. 22 Feb 2016.