Nezvinyorwa zvehupenyu zvisinganyanyi kukoshesa pfungwa uye zvimwe zvechokwadi muUnited States, varwere vane chirwere chinoputira chirwere (IBD) vachava nemibvunzo yakawanda pamusoro pemishonga iyi. Biosimilars ndeye biologic zvinodhaka, asi hazvisi zvakafanana nezita-brand biologic zvinodhaka. Izvi zvinovhura mibvunzo yakawanda - kune vose vanachiremba nevarwere-pamusoro pekuti biosimilar inogona kushandiswa sei kubata BHD.
Nepo biologic zvinodhaka zvinoshandiswa kugadzirisa zvimwe zvinhu kunze kweBD, kutsanangura zvinoguma kubva pakudzidza kwakaitwa kune varwere vasina IBD kwakaoma. Ichi ndechokuti varwere veBD vane maitiro akasiyana emishonga iyi mumitumbi yavo kupfuura vanhu vasina IBD. Nokudaro, inogona kunge iri nguva isati yatanga tine daka rakanaka kubva pane zvidzidzo zvechirwere zvakagadzirwa zvakanaka pamusoro pezvinodhaka zvebiosimilar kune vanhu vane IBD.
Hatisati tine mhinduro dzemibvunzo yakawanda, asi isu tinogona kushandisa izvo zvatinoziva tatoziva uye zvinouya nemamwe mazano. Hezvino izvo zvatinoziva iye zvino pamusoro pezvinotarisirwa nevarwere kubva kune zvinyorwa.
Biologic Zvinodhaka
Biologic zvinodhaka mishonga inoshandiswa kurapa zvirwere nemamiriro ezvinhu, uye muBD, dzimwe nguva inoshandiswa kuderedza kana kumira kupisa mumuviri. Mishonga inonzi Biologic inobvumirwa kuraramisa IBD inosanganisira Humira (adalimumab) , Cimzia (certolizumab pegol) , Remicade (infliximab) , Tysabri (natalizumab), Simponi (golimumab) , uye Entyvio (vedolizumab) .
Kana Murefu "Achikundikana" Biologic, Iyo Biosimilar Inosarudza Here?
Sezvatinoziva, munhu wose ane IBD anopindura mishonga zvakasiyana. Vamwe vanhu vane Crohn's disease kana ulcerative colitis havagoni kupindura mishonga ye biologic kana kuti vangasava nehanya nazvo kupfuura nguva. Kuvhiringidza kana zviratidzo hazvibatsirwi nemishonga kana kuti vangatanga kudzoka pasinei nekushandiswa kwemishonga.
Apo izvi zvinenge zvichiitika zvinowanzotaurwa sekuti "kukundikana" mushonga. Izvi hazvisi kukanganisa kune chikamu chemurwere kana chiremba kana chirwere, asi iri izwi rinoshandiswa. Zvinorevei ndezvokuti mushonga uyu hauna kushanda pakuvhiringidza kubva kuBD, uye kana usingashandi, zviri pachena kuti unomira uchiedza. Vanachiremba vangave vachitaura nezvezviitiko zvakasiyana sekukundikana kwe "primary" kana "secondary", zvichienderana nokuti mushonga wacho hauna kumboshanda zvachose, kana kuti wakashanda kwekanguva ndokubva wamira.
Apo murwere asingatendi kune zita-brand biologic, sarudzo inoda kuitwa pamusoro pemishonga yekuedza nayo inotevera. Kuedza mishonga iyo inonzi biosimilar yezita-brand biologic, zvisinei, inofungidzirwa kuti haisi yekusarudza. Kana, somuenzaniso, murwere ane allergiki (kana ane zvinopesana nezvinoitika) kune chimwe chizivo chechilogi, murwere angangodaro anokonzerwa nea biosimilar. Uye, nepo biosimilar isingazove yakanyatsodhindwa yezita-brand biologic, ikozvino yaifunga kuti murwere asingatendi kune imwe angave asingagoni kupindura kune imwe. Nokudaro, zvinofungidzirwa kuti biosimilar haingazopi imwe nzira yekurapa kumurwere anenge atadza kukwanisa biologic (uye vice-versa).
Kuchinja Pakati Pezvinyorwa zveBioologics uye Biosimilars
Pane kunetseka kuti varwere vanogona kushandurwa pakati pe biologic uye biosimilar vasina ruzivo kana kubvumirana. Izvi dzimwe nguva zvinowanzoitika nemishonga yemishonga : chiremba angaronga zita racho, asi kambani yveshuwarisi iri kutsvaga mari yekuchengetedza mari, saka mishonga inotanga kuchinjwa kumutambo.
Panyaya ye biologic, panguva ino, hazvizivikanwe zvichaitika kana murwere ari kuita zvakanaka pane imwe chirwere chechi biicic inoshandiswa kune zvinodhaka zve biosimilar. Hapana humwe humwe uchapupu hunogumisa pamusoro penyaya iyi. Zvisinei, zvinofungidzirwa kuti nokuti biosimilar uye biologic hazvisi zvakafanana, hazvirevi kuti zvingashandurwe nenzira iyi.
Nyanzvi dzinoratidza kuti kana murwere ari kuita zvakanaka, vanofanira kuramba vachiwana mishonga yavave varipo, kana iyo iyo zita-chinonzi biologic kana kuti biosimilar.
Dzimwe hurumende dzakapedza mutemo maererano nehupenyu, uye vamwe vane mutemo unotarisira, asi kwete nyika yose iri kuifunga. Muzviitiko zvizhinji, mutemo unosanganisira mutauro unoita kuti zvive pachena kuti ndiye chete mishonga inorayirwa nachiremba (ingava biologic kana biosimilar) inofanira kushandiswa, uye kushandiswa kunobvumirwa chete kana chiremba uye murwere vachibvumirana.
Kuvhiringidzika kwevashandi veBDI ndeyekuti makambani einishuwarenzi angamanikidza varwere kuti vachinje mishonga kana biosimilar isingadhuri, kunyange kana biologic yava kusvika zvino. Panyaya yekushandura pakati pezvigadzirwa zve biologics uye biosimilars, Dr. Scott Plevy, Disease Area Stronghold Leader, Inflammatory Bowel Disease paJanssen Research & Development akati (kutaura kukurukurirana, February 2016) "iwe hausi kuparadza nekubudirira nezvirwere izvi."
Pane Nzvimbo Yevasayendisiti?
Kunyange zvazvo kushandura pakati pe biologic uye biosimilar hakufungi nzira inobatsira yekurapa IBD panguva ino, chaizvoizvo kutanga kurapwa ne biosimilar kunogona kusarudzwa kune vamwe varwere. Izvi zvinopa imwe nzira yekurapa, iyo inhau dzakanaka kuvarwere. Kuita shanduko kubva ku biosimilar kusvika ku biologic kunogona kunge iri dambudziko, saka hazvifungidziri kuti ndiyo inosarudzwa. Kana murwere ari kuita zvakanaka pane biosimilar, zvinofungidzirwa kuti mishonga imwechete inofanira kuramba ichienderera mberi, yakafanana nemamiriro akasiyana-siyana.
The Price of Biosimilars
Parizvino, kuti mari inosvika sei mumusika ichiri chisingazikamwi. Vakawanda vari kufanotaura kuti zvizvarwa zvinodhura zvinodhura zvishoma pane biologics. Zvisinei, iyi haisi chivimbiso, uye kune kambani yekambani inoita biosimilar kutengesa mutengo wakafanana neyo inopomerwa nemugadziri we biologic. Nemhaka yokuti inishuwarenzi inopesana, mamiriro ezvinhu achazove akavakirwa pamunhu oga uye kana kwete kana kambani yemishonga inobata patent pamushonga we biologic inopa kuenzanisa kwekutengesa kana chimwe chiyero chekubhadhara mari, sechirongwa chekubatsira varwere. Kune zvakawanda zvakasiyana-siyana zvinosanganiswa mumitengo, zvakaoma kufanotaura. Inofungidzirwa kuti mari inogona kunge yakakwikwidza zvakakwana, kune zvose biosimilars uye biologics, iyo ichave yakakosha kune varwere.
The Bottom Line
Mamiriro ekurapa kusarudzwa kwevashandi veBD muUnited States ari kuchinja. Kugamuchirwa kwemishonga inonzi biosimilar kuunza mibvunzo yakawanda pamusoro pekushandisa kwavo inogona kupindurwa chete munguva. Pane zvishoma zvinyorwa zvokuenderera mberi kusvika ikozvino nemishonga inonzi biosimilar, asi nyanzvi dzezvehutano hwehutano dzakagadzirisa manyorero ekuti angashandiswa zvakanakisisa sei nevarwere vane IBD nemamwe mamiriro. Pachava nezvimwe zvidzidzo nemitemo uye mirayiridzo inowanikwa mumwedzi inouya, asi, sezvinogara iri, gastroenterologist yako ichava iyo yakanakisisa inopa ruzivo pamusoro pemishonga yako yekurapa.
Sources:
US Food and Drug Administration. "Ruzivo pamusoro pezvinyorwa zvevanhu." FDA.gov. 22 Feb 2016.