Fahamka Doorka Daroogada
Ereyga "biobetter" waxaa loola jeedaa daroogada sumeeyaha ah ee dib u habeyn ah kaas oo ku jira fasalka isku mid ah biopofarmasic laakiin hadda ma aha mid isku mid ah; waxaa lagu hagaajiyay asalka dhabta ah. Xirfadlayaasha waxay ku dhisaan guushii hore ee la ansixiyey, bayoolajiyada la ansixiyay laakiin waxaa loo tixgeliyaa inay ka yartahay khatar ganacsi marka loo eego horumarinta nooc cusub oo ah bayooloji.
Labo maroodi maahan daawooyin cusub, mana ahan noocyo mukhaadaraad ah oo daroogo ah.
Inkasta oo ay dad badani tixgeliyaan biosimilar si ay u noqdaan noocyada guud ee daawooyinka biotech, maahan suurta gal ah in la abuuro daroogada jimicsiga. Taasi waa sababta bioxamiinada waxaa laga soo saaraa noolaha noolaha - sida xayawaanka ama bakteeriyada - laguma koobi karo.
Congress wuxuu ogolaanayaa Maamulka Cuntada iyo Dawooyinka ee Maraykanka (FDA) inuu sameeyo horumarinta jidka loo maro jidka biosimilars , laakiin geeddi-socodku waa mid adag oo waa in uu wax ka qabtaa welwel badan, iyo waddada aan wali la dhamayn.
Halkii laga sugi lahaa habka loo dhammeeyo, qaar ka mid ah dawooyinka daroogada ayaa doorbidaya inay maalgashadaan horumarinta biobaha.
Faa'iidooyinka Loo Bixiyo Horumarinta Biosimilar ee Faa'iidada Kobcinta Biobetter
Noocyada abuurista abuurista ee hore - sida insulin iyo qaababka hore ee hormoonka koritaanka hormoonka bani-aadamka - guud ahaan daawooyinka si dhakhso ah loo sii daayo oo la keeno faleebo ama subageyn. Khabiirada waxaa lagu sameeyaa iyadoo la adeegsanayo borotiinka ama glyco-engineering taas, khubarada ayaa leh, waxay yareeyaan halista immunogenicity, waxay daroogada ka dhigtaa mid ammaan ah oo waxtar leh, waxayna u baahan tahay daaweyn hooseeya.
Qalabka xayawaanku wuxuu bartilmaameed u yahay astaamaha asalka ah, laakiin saamaynta ay ku yeelanayso bartilmaameedku wuxuu soconayaa waqti dheer.
Sababta oo ah biobetter waa daroogo cusub, waxay ku raaxeysan doontaa 12 sano oo ah ilaalin suuqa ah ee Maraykanka iyo suuqyada kale, oo aan ka duwaneyn biosimilar. Waxaa intaa dheer, xitaa walxaha waxay u muuqdaan inay leeyihiin kharashka R iyo D hoosaad.
Qaar badan oo ka mid ah jimicsiga abuurista ee ugu horreeya ayaa ka baxa-patent iyo tartan ka iman doona biosimilars.
Waxay u muuqataa in la arko haddii biobetters uu noqon doono tartan.
Shirkadaha Horumarinta Habraaca
Novo Nordisk, Merck & Co, Roche Group, Biogen Idec, Amgen, Sanofi-Aventis, Eli Lilly, iyo GlaxoSmithKline waxay dhammaantood muujiyeen xiisaha horumarinta daawooyinka biobetter. Qaar ka mid ah ayaa helaya shirkado yaryar, kuwa cusub ee abuura biopharmaceutical kuwaas oo leh dhuumo dherer ah.
Tusaale ahaan, Pharma British AstraZeneca waxay iibsatay shirkadda Biotech MedImmune oo ku talo jirta inay diirada saaraan R & D.
The Edmonton, Alberta, shirkadda Compass Biotechnologies, Inc., ayaa lagu dhawaaqay dabayaaqadii Disember 2011 in ay diiradda saarayso hormarinta borotiinka kor u kaca ee biosimilar sida EPO iyo G-CSF.
Compass ayaa sidoo kale heshiis la gaari doonta borotiinka dib-u-kicinta ee biosimillada laga soo saaro unugyada "CHO" oo ka yimid PanGen Biotech oo Seoul, South Korea, iyo heshiis la leh Arecor Ltd. ee Cambridge, England, si loo horumariyo biobetter, habka kulaylka ah ee cagaarshowga ganacsiga Tallaalka B.
K. Srinivas Sashidhar, oo ah falanqeeye cilmibaaris ee Frost & Sullivan, ayaa qoray in "Biobetters uu noqon doono fursadda weyn ee soo socota ee shirkadaha kiimiko ah iyo CROs.
Ka-qaybgalayaasha suuqyada ayaa rajeynaya in ay iskaashi la sameeyaan shirkadahaas si ay u horumariyaan noocyada horumarinta ee bayoolojiga. Ururada si wacan loo yaqaan oo ku saabsan hal-abuurka iyo waayo-aragnimada jeneriga ayaa laga yaabaa inay ugu fiicanyihiin si ay u gaaraan guul.
Qaar ka mid ah caqabadaha ugu waaweyn ee haysta cilmi-baarayaasha ku lug leh horumarinta xayiraadaha ayaa ah inay isku mid noqdaan mishiinka aasaasiga ah iyo helitaanka macluumaadka shirkadda asaliga ah, sida laga soo xigtay Sashidhar.
Waxa kale oo loo yaqaanaa: biosuperiors
Tusaale
Shirkadda Jarmalka Jarmalka Glycotope waxay horumarineysaa TrasGEX, oo ah xeel dheer oo Roche ah ee daroogada ah ee lagu magacaabo Herceptin (trastuzumab). TrasGEX waxay bartilmaameed ka dhigtaa suuxiyaha HER2 kaas oo ka badan kuwa loo yaqaan kansarka qaarkood, oo ay ku jiraan naasaha HER2-naasaha iyo kansarka caloosha.