Ka Hoʻomaopopoʻana i kēia Keʻena o ka Haumāna
ʻO ka hua'ōlelo biobetter e pili ana i kahi lāʻau lapaʻau e like me keʻano o ka meaola e like me ka biopharmaceutical i kēia manawa akā,ʻaʻole like; uaʻoi aku ka maikaʻi ma mua o ke kumu. Hoʻokumuʻia ka Biobetters ma ka holomua o nā'ōnaehana honua, akā, ua manaʻoʻia heʻuʻuku o kaʻoihanaʻoihanaʻoi aku ma mua o ka hoʻomohalaʻana i kahi papa hana'anoola.
ʻO ka lāʻau lapaʻauʻaʻoleʻo ia i nā lāʻauʻona hou loa, aʻaʻole lākou he lapaʻau lāʻau likeʻole.
ʻOiai ka nui o nā kānaka e nānā i nā biosimilars e lilo i mau hua'ōlelo laulā o nā lāʻau lapaʻau,ʻaʻole hiki ke hana i kahi lāʻau olaola lāʻau. ʻO ia ke kumu o ka biopharmaceuticals i huaʻia i loko o nā meaola ola - e like me nā holoholona a me nā huamona - aʻaʻole hiki ke kope kopeʻia.
Uaʻae aku kaʻahahui i ka US Food and Drug Administration (FDA) e hoʻomohala i keʻano o ka biosimilars alanui, akā he mea paʻakikī ia e hoʻoponopono i nā mea he nui wale, aʻaʻole i hoʻopauʻia ke ala.
Ma mua o ka kaliʻana no ka hoʻopauʻiaʻana o ke kaʻina hana, aia kekahi o nā mea hana lāʻau lapaʻau e hoʻoholo i ka hoʻokomoʻana i nā biobetters.
Nā Pōmaikaʻi o ka Hoʻolālā'Ila likeʻole me ka makemake i ke kūkuluʻana i kahi mea kanu
ʻO nā kumuhana ola mua - e like me ka insulin a me nāʻano hou o ka hoʻoulu ulu kanaka - e hele koke koke aku - e hoʻopauʻia nā lāʻau lapaʻau i hoʻolakoʻia ma o ka infusion a iʻole keʻanoʻaoʻao. Hoʻokumuʻia nā biobetters e hoʻohanaʻia ana i ka protein a me ka glyco-engineering, i'ōleloʻia e ka poʻe akamai, i ka hopena o ke immunogenicity, hiki ke mālama i ka lāʻau lapaʻau aʻoi aku ka maikaʻi, a ke koi aku nei i ka lalo.
ʻO ka biobetter kahi pahu like hoʻokahi e like me ke kumu olapili kumu mua, akāʻo kona hopena ma luna o ka pahuhopu e mau no kekahi manawa lōʻihi.
No ka mea he lāʻau hou ka biobetter, eʻoliʻoliʻo ia i nā makahiki he 12 o ka palekana ma ka mākele ma US a me nā māhele'ē aʻe, e like me ka mea likeʻole. Eia kekahi,ʻo nā biobetters ka mea e emi ai nā kumu kūʻai R a me D.
E hele ana nā mea he nui o nā hanauna ola honua -ʻaeʻana i kaʻaelike a ke kū'ē i ka hakakā mai nā biosimilars.
Ke hoʻomauʻia nei eʻikeʻia inā he hoʻokūkū ka honua.
Nā Pūʻulu Hoʻolālā Ola
Novo Nordisk, Merck & Co, Roche Group, Biogen Idec, Amgen, Sanofi-Aventis, Eli Lilly, a me GlaxoSmithKline ua hoʻopuka nui i ka hoihoi i ka hoʻomohalaʻana i nā lāʻau laʻau. Nui nā poʻe i loaʻa nā kamaliʻi biopharmaceutics hou, a me nāʻoihana pipili.
No ka laʻana, ua kūʻai akuʻo'AstraZenecaʻoʻAmelikaʻo Bioyune i kaʻenehana biotech Mediemmune e manaʻo nei e kau i nā kumuhana R & D.
Ua hōʻikeʻiaʻo Edmonton, Alberta, Komisina Compass Biotechnologies, Inc., i ka hopena o Kekemapa 2011 e hoʻomau ana i ka uluʻana i nā meaola likeʻole e like me EPO a me G-CSF.
Loaʻa i ka Compass he'elike e hoʻopuka i nā biosimilars protein pūnaewele i hanaʻia ma nā "CHO" mai PanGen Biotech o Seoul, South Korea, a me kahiʻaelike me Arecor Ltd. o Cambridge,ʻEnelani, e hoʻoulu i ka biobetter, ka hoʻomehana wela o ka maʻi hepatitis B olaʻo B.
Ua kākauʻo K. Srinivas Sashidhar, he mea noiʻi noiʻi me Frost & Sullivan, "ʻO ka Biobetters ka manawa hou e hiki ai i nā hui biopharmaceutical a CRO.
Hiki i nā mea kūʻai kālā ke nānā i mua o ka hana pūʻana me kēia poʻe hui no ka hoʻomohalaʻana i nā manaʻoi aʻe o nāʻano biologics. ʻO nā hui iʻike nuiʻia no ka hana hou a me kaʻike pū me generics, hiki paha ke kūpono i kahi kūpono e holomua ai me nā biobetters. "
ʻO kekahi o nā pahuhopu nui loa e kū ana i mua o nā mea noiʻi i ka hanaʻana i nā biobetters, e hoʻokō i ka likeʻana me ka mea i hoʻomakaʻia e ka mea kanu a me ka loaʻaʻana o kaʻike i kaʻikepili o ka hui, e like me Sashidhar.
Nā mea iʻikeʻia e like me: nā mea kanu
Pākuʻi
Ke kūkulu neiʻo Glycotopeʻo Kekemapa kālepa Kelemānia TrasGEX,ʻo kahi biobetter o Roche i ka lanakila ma muli o ka lāʻau lapaʻau Herceptin (trastuzumab). Hoʻolālāʻo TrasGEX i ka loaʻa o ka HER2 i hōʻikeʻia ma nā maʻi āpau, e like me ka umauma HER2-a me nā maʻi āpau.