Ama-Biosimilars Anendawo, Kodwa Ayingeyona Eyodwa Yezinto Eziphilayo
Kuyini i-biologic?
I-biologic uhlobo lomuthi oludalwa ngaphakathi kweseli eliphilayo. Ososayensi badala imithi ye-biologic ngokushintsha i-DNA ngaphakathi kwamangqamuzana athile. Amaseli ashintshwa ukuze alungiselelwe ukuphindaphinda kuze kube phakade. Lapho amangqamuzana ekwazi ukuziphindaphinda, abuye aguqulwe ukuze ahlelwe ukudala i-antibody ukuthi ososayensi bafuna.
Uma kwenzeka ezinye izidakamizwa ze-biologic ezisetshenziselwa ukwelapha isifo sofuba (IBD) , izidakamizwa ezidalwa yizo ezisebenza ngokumelene ne- tumor-necrosis factor (TNF) .
Imithi ye-biologic esetshenziswa ukuphatha i-IBD yi- Humira (adalimumab) , i- Cimzia (certolizumab pegol) , i- Remicade (infliximab) , i-Tysabri (natalizumab), i- Simponi (golimumab) , ne- Entyvio (i-vedolizumab) . Zonke lezi mithi ye-biologic zibizwa ngokuthi imikhiqizo emisha, futhi zenziwa kuphela yizinkampani ezizihlakulele. Imikhiqizo emisha, embonini yezokwelapha, imikhiqizo emisha engatholakali kwenye inkampani, futhi ingase ibe ngaphansi kwelungelo lobunikazi. Zidalwa endaweni elawulwayo, eyakhiwe, ehluke kakhulu kunemithi ekhishwa ngamakhemikhali.
Ezinye zemithi ye-biologic eyadala i-IBD yi-TNF inhibitors. Abantu abane-IBD banamazinga aphezulu e-TNF emizimbeni yabo kunabantu abangenawo i-IBD, yingakho i-TNF kucatshangwa ukuthi iyingxenye yokuthi kungani ukuvuvukala okuhambisana ne-IBD kuqhubeka futhi kuthinta ipheshana lokugaya.
Imithi yokulwa ne-TNF isebenza ngokuvimbela i-TNF nokuyivimbela ukuthi ingabangeli ukuvuvukala. I-Entyvio i-gut-homing α4β7 integrin ephikisanayo eyenza ngokuvimba amaseli amhlophe egazi, okucatshangwa ukuthi abe negalelo ekuvukeni, ekubambeni ngaphakathi kwendlela yokugaya.
Imithi ye-biologic isetshenziselwa ukwelapha izimo eziningi kune-IBD, nayo isetshenziselwa ukuphatha ezinye izifo ezizivikela nge-immune noma izivivinya-mzimba ezifana ne-rheumatoid arthritis, i-psoriasis, i-anondlosing spondylitis, ne-hidradenitis suppurativa.
Ingabe ama-Biosimilars afana namaGenerics?
Ama-biosimilars avame ukuchazwa ngokuthi "ojwayelekile" wemithi ye-biologic. Nokho, lokhu akuyona indlela enembile yokuchaza i-biosimilar. Uma singena esikhungweni sezidakamizwa, sivame ukukhetha ukuthenga igama-umuthi wesidakamizwa, nesidakamizwa se-bioquivalent - generic. Uma ubheka ukupakisha kokubili imithi, uzobona izithako ezisebenzayo ziyafana.
Ukuze inkampani ithengise umkhiqizo ojwayelekile, i-FDA kumele ivumelane ukuthi i-generic iyashintshashintsha nomkhiqizo omusha. Lokhu akusho ukuthi i-generic iyinto efanayo, noma kunjalo. Kukhona okungase kube khona ukungezwani kwezithako ezingasebenzi, kodwa isithako esisebenzayo, ngokusho kwe-FDA, efanayo.
I-biosimilar ilayisensi yi-FDA futhi kufanele ifane ne-biologic kuyo:
- Inqubo yesenzo
- Umzila wokuphatha (njengokungenisa ukumnika noma umjovo)
- Isilinganiso
- Amandla
I-biosimilar ayifani ne-biologic, noma kunjalo, futhi ukungafani okuhlukile kuvunyelwe. Ukuklama nokudalwa kwesidakamizwa se-biologic kunzima kangangokuthi i-biosimilar ngeke ifane ne-biologic. Ngenxa yokuthi asinayo imininingwane eminingi yesayensi okwamanje, izazi zisekuphikisana ngokuthi ngabe i-biosimilar izosebenza ngokufanayo ngendlela efanayo ne-biologic.
Ngenkomfa yeJanssen eyabanjelwa isayensi ngemuva kwezinto eziphilayo, uMichael Yang, uMengameli we-Immunology eJanssen Biotech uthe "ama-biologics aphilayo amaprotheni, futhi amaprotheni aphilayo awakwazi ukukopishwa." Ngenxa yokuthi umkhiqizo we-biologic ukhulile ngaphakathi kohlobo oluthile lweseli, akuyona into engabuyiselwa kabusha. I-biosimilar izohluka nge-biologic, ngendlela efanayo, njengoba i-Yang echaza, umuthi owodwa we-oki uhlukile kwenye, nakuba bobabili behlukaniswa njengezihlahla ze-oak.
Yini Engayenza Abagulayo be-IBD?
Njengoba imikhiqizo eminingi ye-biosimilar iza emakethe, kuyoba neminye imithi yokukhetha imithi etholakalayo kubantu abanesifo sikaCrohn kanye nesifo sofuba esiswini.
Iziguli ezithola izidakamizwa ze-biologic noma izidakamizwa ze-biosimilar kufanele zizijwayele nemithetho esesimweni sayo mayelana ne-biological and biosimilars.
Ngaphambi kokuthola ukumnika isikhungo esikhungweni sokungenisa isikhala noma esibhedlela, iziguli zingabuye zicele ukuqinisekisa ukuthi zithola imithi eqondile edokotela wabo, "njengoba kubhaliwe." I-biosimilar kufanele ibe negama legama elihlukile kune-biologic, ngakho-ke ukufunda ilebuli emithini yemithi kubalulekile. Uma isimo sakho singenalo umthetho, noma umthetho awunamandla ngokwanele, xhumana nabamele bendawo bakho ukuqinisekisa ukuthi bayazi imibono yakho, njengoba isiguli esithintekile kule mithetho.
Umthombo:
I-Cauchi R. "Imithetho Nemithetho Yomthetho Okuhlobene Nezokwelapha Ze-Biological and Restoration of Biosimilars." Inkomfa kaZwelonke yeziNyunyana zoMbuso. Jan 4 2016.
Ukuphathwa kwe-US nokuDrug. "Ulwazi lwabathengi (ama-Biosimilars)." FDA.gov. Aug 27 2015.