I-Biologics, eyaziwa ngokuba yiziyobisi ze-biological okanye i-biologic agents, iimvavanyo, izikhuselo, kunye nezokwelapha eziye zaphuhliswa kwaye zenziwa ngeenkqubo ze-biological ngokusebenzisa imithombo yabantu, izilwanyana okanye izilwanyana ezincinci. Oku kuhambelani neziyobisi zonyango, ezenziwe kwiinkqubo zamachiza.
Kukho nawuphi na inani lezinto ezithathwe ngabantu, izilwanyana okanye izilwanyana ezincinci ezisetyenziselwa kwimveliso yezinto eziphilayo, ezifana noshukela, iiprotheni, i-nucleic acid, iiseli, igazi okanye iifom.
Ukusebenzisa i-biotechnology, badibaniswe okanye baqhutywe ukwenza izinto ezinokusinceda sihlolisise, siphathe, siphathe, okanye siphilise izifo kunye nezimo.
Phakathi kwezinto zokuqala ze-biological kwakuyi- insulin , eyona nto yayifumaneka kwizilwanyana. Imveliso ye-insulin yanamhlanje ingaba yimiphumo ye-DNA ephindaphindiweyo, indlela eyahlukileyo, kodwa i-biologicalic in nature.
Iigonya zizinto eziphilayo eziye zafunyanwa ngeenkulungwane. Ziye zaphuhliswa zisebenzisa inxalenye yesifo okanye intsholongwane ebangela isifo esithintekayo. Le nto ingaba yintlupheko ebulawayo okanye emnene yentsholongwane, okanye inokuba yiprotheni ecocekileyo, iswekile okanye enye inxalenye yegciwane.
Ngokubhenela umntu kulolu hlobo olulungiselelwe kwisifo okanye intsholongwane ngaphambi kokuba bagule, umzimba uphatha ngokuzakhela izifo ezichasene nesi sifo. Kamva, xa kutyhila, isigulane asiyi kuhlakulela eso sifo.
Inkqubo yonke i-biological.
Ezinye iimvavanyo eziqhelekileyo kunye neendlela zokwelapha ziyi-biological, nayo. Iimveliso zeGazi ezisetyenziselwa ukuxilongwa , iimvavanyo ezininzi zokuphefumula kunye nezibhamu, imithi yonyango efana neleyo esetyenziselwa ukunyanga iimpawu zokuqeda umama, kunye neengcambu zecandelo lokusetyenziswa okanye ukuphuhliswa kwamanye ama-biologic agents.
Uluhlu lwezinto eziphilayo
Ukuhlanganiswa kwimiba yezibonelelo, nolu luhlu lwezinto eziphilayo:
- zokugonya
- insulini
- interleukins
- ukukhula kwabantu
- iirmone zokwelapha, ezifana nokusetyenziswa kwe-estrogen okanye i-testosterone
- iimvavanyo ukukhupha abaxhasi bamagazi be-HIV okanye ezinye ii-agent ezithathelwanayo
- igazi kunye nemveliso yegazi yokumpontshelwa igazi
- igazi kunye nemveliso yegazi esetyenziswa ekuveliseni kunye neminye imikhiqizo
- iifutshane ze-biologic ezisetyenziselwa ukuphucula iimvavanyo zokungabikho komzimba kunye nokukhwela kwamanye amazwe
- iiseli zomntu kunye nezicubu ezisetyenziselwa ukutshintshwa (umzekelo, iintambo, iigaments, kunye nethambo)
- i-gene (DNA) yonyango (jonga ngezantsi *)
- zonyango zonyango (jonga ngezantsi *)
Ngolunye lwale luthengiswa phantsi kwegama lomngcipheko onokuthi libonakala ngakumbi, njengeAvastin, Herceptin, Enbrel, Epotin, Remicade, Huma okanye Avonex.
I-Biologics Azinalo Ngokucacileyo Ngokucacileyo Iifani Ezilinganayo
Ngokungafani neziyobisi zamachiza ezindala, i-biologics eninzi ayinayo into echazwe ngokuchanekileyo njengezinto eziqhelekileyo ezilinganayo . I-FDA ichaza i-generics njengokuba isisithako esisisigxina esifanayo njengesiza segama lesigwebo. Akunjalo kuphela, kodwa nabo bafana ne-bioequivalent - banefomathi efanayo, amandla, umgangatho kunye nokusebenza. Kunoko, i-biologics inezinto eziphilayo, ezichazwa ngumthetho ngo-2009.
Biosimilars
I-Biosimilars ziyizidakamizwa ezivunyiweyo yi-FDA ezingenalo ukungafani kliniki kwi-brand ye-brand ye-biologic.
Zifanele zikhuseleke kwaye ziphumelele kwaye zisebenze ngendlela efanayo nemveliso yenkcazelo. Isiza kuthiwa sitshintshana xa sifumana umgangatho we-biosimilarity kwaye kufuneka sikwazi ukutshintshwa nomkhiqizo wokuqala ngaphandle kokwanda kwengozi.
Imirhumo yeziyobisi ze-biosimilar yayigcinwe eMelika ukuya kwinqanaba le-Care Affordable Act ka-2010. Ngenkqutyana ye-Biologicals Price Competition and Innovation Act (BCPI) ka-2009 kunye noMthetho woKhuseleko kwabaPhepheli kunye noMthetho wokuNakekelwa koNyaka ojongene noNyaka ka-2010, i-biological iimveliso zineendlela ezichanekileyo zokunikezelwa kwelayisenisi nge-FDA.
Izidakamizwa ezininzi kunye nezidakamizwa eziguquguqukayo ziya kufumaneka eUnited States kunye nale nguqu kumthetho.
Ngaphambi kuka-2009, amaqela amaninzi afuna ukukhuthaza i-FDA ukuba iqale ukuvumela ukuveliswa kwezinto eziphilayo okanye iinguqu ezilandelelweyo ze-biologics ezindala njengendlela yokugcina imali yeenkqubo zempilo. Ngokomzekelo, i-brand insulin kunye neentlobo ze-insulin zingabiza ukusuka kwi-$ 150 ukuya kwi-1000 ngonyaka ngenyanga. Ukulandelelana ngokulinganayo kungabiza iindleko ezingama-25 kuphela ngenyanga. Xa ukwandiswa inani labantu abafuna ezi zintlobo zonyango, unokubona ukuba ukuvunyelwa kwezi ziphumo zezinto eziphilayo kungasindisa inkqubo yeebhiliyoni.
Abavelisi bakhulu be-biologic bafuna ukuphuhliswa kunye nokuveliswa kwezinto eziphilayo ngenxa yokuba abazange bafune ukuncintisana nezonyango ezingabizi, kodwa ezichanekileyo (landela imali). Bachaza iingxaki zokukhusela kwinkqubo yophuhliso kunye nokungabikho kobungqina bokuthi ezi ziyobisi ziza kusebenza ngendlela efanayo.
Umthombo
Ulwazi lwaBathengi (ii-Biosimilars) - Ulawulo lwe-US nokuLawulwa kweziMilutha 8/27/2015.