Ukuqonda Lo Msebenzi Wezidakamizwa
I-biobetter ibhekiselele kwiziyobisi zeprotheyini eziphindaphindiweyo ezikwinqanaba elifanayo njenge-biopharmaceutical ekhoyo kodwa ayifani; kuphuculwe ngaphezu kweyayimvelaphi. I-Biobetters yakha kwimpumelelo yezinto ezikhoyo ezivunyiweyo, kodwa zithathwa njengezingcipheko zorhwebo kunokuqulunqa iklasi entsha ye-biologic.
Ii-Biobetters azikho iziyobisi ezitsha ngokupheleleyo kwaye aziyiziguqulelo eziqhelekileyo zamachiza, nokuba kunjalo.
Ngelixa abaninzi banokucinga ukuba iinguqu zezinto eziphilayo ziguqulelwa kwii-biotech izidakamizwa, akunakwenzeka ukudala i-biological drug. Kungenxa yokuba ii-biopharmaceuticals ziveliswa kwizinto eziphilayo-ezifana nezilwanyana okanye ibhaktheriya-kwaye ayikwazi ukukopishwa ngqo.
I-Congress inikwe igunya kwi-US Food and Drug Administration (i-FDA) ukuphuhlisa indlela yokulawulwa kwemigqaliselo yokuziphatha , kodwa inkqubo yinkambinkimbi enokuthi ihlangabezane neenkxalabo ezininzi, kwaye indlela ayizange igqitywe.
Esikhundleni sokulinda ukuba inkqubo igqitywe, abanye abenzi beziyobisi bayakhetha ukutyalomali ekuphuhliseni i-biobetters.
Izinzuzo zokuPhucula ukuThuthukiswa kweBosimilar Development in favor of Developing Biobetter
Isizukulwana sokuqala sezinto eziphilayo-ezifana ne-insulin kunye neendlela zokuqala zokuvuselela i-hormone yokukhula komntu-ngokuqhelekileyo iziyobisi ezikhutshwa ngokukhawuleza ezithunyelwa nge-infusion okanye ngaphantsi. Ii-Biobetters ziphuhliswa zisebenzisa iprotheni okanye i-glyco-ingqineli, ezo zitsho iingcali, zinciphisa umngcipheko we-immunogenicity, yenza ukuba izikhusela zikhuseleke kwaye zisebenzise ngakumbi, kwaye zifuna i-dosing ephantsi.
I-biobetter inomxholo ofanayo kunye ne-original biological, kodwa isiphumo sayo ekujoliswe kuyo kuqhubeka ixesha elide.
Ngenxa yokuba i-biobetter isilwanyana esitsha, iya kuvuya iminyaka eyi-12 yokukhuselwa kwemakethi e-US nakwezinye iimarike, ngokungafani ne-biosimilar. Ukongeza, ii-biobetters zivame ukuba neendleko eziphantsi ze-R ne-D.
Uninzi lwezizukulwana zokuqala zezinto eziphilayo zihamba-patent kwaye ziya kujongana nokukhuphisana kwizinto eziphilayo.
Kuhlala kubonakala ukuba ii-biobetters ziya kukhuphisana.
Iinkampani eziphuhlisa ii-Biobetters
I-Novo Nordisk, i-Merck & Co, iQela le-Roche, i-Biogen Idec, i-Amgen, i-Sanofi-Aventis, i-Eli Lilly kunye ne-GlaxoSmithKline baye babonisa umdla ekuveliseni iziyobisi ze-biobetter. Abaninzi banokufumana iinkampani ezincinci, ezintsha ze-biopharmaceutical ezithembisa amapayipi athembisayo.
Ngokomzekelo, i-british pharma AstraZeneca ithenge inkampani ye-biotech MedImmune enenjongo yokugxila kwi-biometric R & D.
I-Edmonton, i-Alberta, inkampani yeCompass Biotechnologies, Inc., yabhengezwa ngasekupheleni kukaDisemba 2011 ukuba ijolise ekuphuhlisweni kweeprotheni eziphilayo eziphuculweyo ezifana ne-EPO kunye ne-G-CSF.
I-Compass inesivumelwano sokufumana imithombo yamaprotheni ephindaphindiweyo eyenziwe kwii "CHO" zamaseli ezivela kwi-PanGen Biotech yaseSeoul, eMzantsi Korea, kunye nesivumelwano kunye neArecor Ltd. yaseCambridge, e-Ngilani, ukuphuhlisa i-biobetter, ukwakheka kobushushu be-hepatitis Yokugonya B.
U-K. Srinivas Sashidhar, umhlalutyi wophando noFrost & Sullivan, wabhala ukuba "ii-Biobetters ziya kuba yithuba elikhulu elilandelayo kwiinkampani ze-biopharmaceutic and CROs.
Abathathi-nxaxheba beemakethe bangabheka phambili ekusebenzisaneni nale nkampani ukwenzela ukuphucula iinguqu eziphuculweyo zezinto eziphilayo. Imibutho eyaziwayo ngokutsha kunye namava kunye nama-generics inokuba yindawo efanelekileyo yokuphumelela kwi-biobetters. "
Ezinye zeengxaki ezinkulu abajongene nabaphandi ababandakanyekayo ekuphuhliseni i-biobetters ziza kufumana ukufana kwimilekhi yezilwanyana kunye nokufumana ukufikelela kwidatha yenkampani evela kwimoya, ngokweSashidhar.
Kwaziwa nangokuthi : i- biosuperiors
Umzekelo
Inkampani yaseJamani ye-biotech i-Glycotope iphuhlisa i-TrasGEX, i-biobetta ye-Roche eyimpumelelo ye-oncology drug Herceptin (trastuzumab). I-TrasGEX ijolise i-HER2 receptor evezwe ngokugqithiseleyo kwii-cancer ezithile, kubandakanywa ne-HER2-positive nesifuba esiswini.