Kunzwisisa Dhiyabhorosi Iri Dhiyabhorosi
Izwi rokuti biobetter rinoreva reprobinant protein yemishonga inowanikwa mukirasi imwechete yakadai seyakararama biopharmaceutical asi haina kufanana; inovandudzwa pamusoro pepakutanga. Biobetters inovaka pakubudirira kwezvinoitika, zvibvumirano zvinogamuchirwa nehupenyu asi zvinoonekwa sechepakati pengozi yezvokutengeserana pane kugadzira chikwata chitsva chebiologic.
Biobetters haisi mishonga mitsva zvachose uye haisi yemhando yezvinodhaka, zvimwe.
Kunyange zvazvo vakawanda vachifunga nezvemhando dzezvinyorwa zvekushandiswa kwemashoko ezvinyorwa zvezvigadzirwa zvebiotech, hazvibviri kugadzira mishonga yemiti inonzi biologic. Izvozvo ndezvokuti biopharmaceuticals inobudiswa muzvinhu zvipenyu - zvakadai sezvipfuwo kana mabhakitiriya - uye hazvikwanisi kunyorwa zvakajeka.
Congress yakagamuchira US Food and Drug Administration (FDA) kukudziridza nzira yekugadzirisa nzira yemagariro , asi iyo nzira yakaoma inofanira kutarisa zvinetso zvakawanda, uye nzira isati yapera.
Panzvimbo pokumirira kuti chirongwa chacho chizadzikiswe, vamwe vashandisi vezvinodhaka vari kusarudza kusima mukuvandudzirwa kwebiobetters.
Makomborero ekuputika Biosimilar Kubudirira Mukuda Kwekuvandudza Biobetter
Chizvarwa chekutanga biologics - chakadai se insulin uye maitiro ekutanga evanhu ekukura kwehomoni - inowanzobudiswa-mishonga inoshandiswa pakarepo kuburikidza nekunyanyisa kana kudarika. Biobetters dzirikudziridzwa vachishandisa protein kana glyco-engineering iyo, nyanzvi dzinoti, dzinoderedza ngozi yekudzivirira muviri, inoita kuti mishonga ive yakachengeteka uye inoshanda, uye inoda kuderedza dosing.
Bhiobetter ine chinangwa chakafanana neicho chokutanga chezvisikwa, asi iyo inogadziriswa inotora nguva yakareba.
Nokuti biobetter mushonga mutsva, ichava nemakore gumi nemaviri ekuchengetedzwa kwemakemikari muU.S. uye dzimwe misika, kusiyana ne biosimilar. Mukuwedzera, biobetters inowanzova nechezasi yeR R neD.
Vazhinji vezera rekutanga biologics vari kuenda-patent uye vachasangana nemakwikwi kubva kumarudzi evanhu.
Rinoramba richionekwa kana biobetters dzichakwikwidza.
Makambani Anokura Biobetters
Novo Nordisk, Merck & Co, Roche Group, Biogen Idec, Amgen, Sanofi-Aventis, Eli Lilly, uye GlaxoSmithKline vose vakaratidza kufarira mukugadzirwa kwemishonga yebiobetter. Vakawanda vari kuwana zviduku, makambani ekutsvaga mabhiopharmaceutical ane mapaipi anovimbisa.
Semuenzaniso, British pharma AstraZeneca yakatenga kambani yebhaotech MedImmune iyo inoda kutarisa ku biobetter R & D.
Edmonton, Alberta, kambani Ikambasi Biotechnologies, Inc., yakashuma pakupera kwaDecember 2011 kuti iri kutarisa kubudirira kwehutachiona hwemaprotiniti eEEPO neG-CSF.
Ikambasi inewo chibvumirano chekubva kune reprobinous protein biosimilars yakagadzirwa mu "CHO" masero kubva kuGenGen Biotech yeSeoul, South Korea, uye chibvumirano neArecor Ltd. yeCambridge, England, kukudziridza biobetter, kushandiswa kwemhepo kunotyisa kwekutengesa hepatitis B vaccine.
K. Srinivas Sashidhar, muongorori wekutsvakurudza naFrost & Sullivan, akanyora kuti "Biobetters ichava mukana mukuru unotevera wemakambani e biopharmaceutical naRCs.
Vatengi vemusika vanogona kutarisira kushamwaridzana nekambani idzi kuitira kuti dzivandudzire shanduro dze biologics. Misangano inonyatsozivikanwa muhutano uye ruzivo nemagetsi inogona kunge yakanyatsogadziriswa kuti ibudirire nebiobetters. "
Zvimwe zvezvinetso zvakanyanya zvinotarisana nevatsvakurudzi vanobatanidzwa mukugadzirwa kwebiobetters ndezvekuita zvakafanana kune molekisi anotanga uye kuwana ruzivo rwezvinyorwa zvemakambani anotanga, maererano neSashidhar.
Uyewo Anozivikanwa Se: biosuperiors
Muenzaniso
Imwe nyanzvi yeGermany yeGotecope inoshandisa TrasGEX, biobetter yeRoche yakawanda kwazvo inobereka inocology drug Herceptin (trastuzumab). TrasGEX inoshuvira HER2 receptor iyo inopfuura-inoratidzwa mune mamwe makondombera, kusanganisira HER2-positive mazamu nemukondombera.