Li-biologics, tse tsejoang hape e le lithethefatsi tsa likokoana-hloko kapa lihlahisoa tsa biologic, ke liteko, mekhoa e thibelang, le mekhoa ea phekolo e entsoeng 'me e etsoa ka mekhoa ea likokoana-hloko e sebelisa batho, liphoofolo kapa likokoana-hloko. Sena se fapane le lithethefatsi tsa meriana, tse entsoeng ka lik'hemik'hale.
Ho na le palo leha e le efe ea lintho tse tsoang ho batho, liphoofolo kapa likokoana-hloko tse sebelisoang lihlahisoa tsa likokoana-hloko, tse kang tsoekere, liprotheine, nucleic acid, lisele, mali kapa lisele.
Ba sebelisa theknoloji ea baeloji, ba kopantsoe kapa ba sebelisetsoa ho etsa lintho tse ka re thusang ho hlahloba , ho tšoara, ho laola kapa ho phekola mafu le maemo.
E 'ngoe ea likokoana-hloko tsa pele ka ho fetisisa e ne e le insulin , eo ka eona e neng e tsoa ho liphoofolo. Lihlahisoa tsa insulin tsa kajeno li ka ba teng ka lebaka la DNA e ncha, mokhoa o fapaneng, empa e sa ntse e le ea tlhaho ea lintho tse phelang.
Liente ke li-biologics tse 'nileng tsa fumaneha ka makholo a lilemo. Li hlahisoa ho sebelisa karolo ea kokoana-hloko kapa libaktheria tse bakang lefu lena le thibeloang. Ena e ka ba lefu le bolailoeng kapa le bonolo la germ, kapa e ka ba protheine e hloekisitsoeng, tsoekere kapa karolo e 'ngoe ea likokoana-hloko.
Ka ho pepesa motho ho itokisetsong ena e entsoeng ho tsoa ho kokoana-hloko kapa libaktheria tseo ho buisanoang ka tsona pele li kula, 'mele o itšoara ka ho haha li-antibodies khahlanong le lefu lena. Hamorao, ha a pepese, mokuli a ke ke a hlaolela lefu lena.
Tshebetso ke tsohle tse phelang.
Litlhahlobo tse ling tse tloaelehileng le mekhoa ea phekolo li teng, hape. Lihlahisoa tsa mali tse sebelisetsoang ho tšeloa mali , liteko tse ngata tsa tlhahlobo ea mafu le li-shots, litlhare tsa hormone tse kang tse sebelisetsoang ho tšoara matšoao a ho khaotsa ho ilela khoeli, le litlhare tsa stem tse sebelisetsoang ho fetisetsa kapa ho nts'etsopele ha mahlahana a mang a biologic kaofela li nkoa e le li-biologics.
Lethathamo la likokoana-hloko
Li kopantsoe ho mehloli e mengata ea lithulusi, mona ke lenane le hloahloa la li-biologics:
- liente
- insulin
- li-interleukins
- li-hormone tsa ho hōla ha batho
- li-hormone therapy, tse kang tšebeliso ea estrogen kapa testosterone
- liteko ho ea shebella bafani ba mali ba HIV kapa ba bang ba tšoaetsanoang
- mali le lihlahisoa tsa mali bakeng sa tšelo ea mali
- mali le lihlahisoa tsa mali tse sebelisoang ho hlahisa lihlahisoa tse ling
- lihlahisoa tsa biologic tse sebelisetsoang ho hlahisa liteko tsa ho ipehela litsing tsa boipheliso le lits'oants'o tse ling
- lisele tsa motho le lisele tse sebelisetsoang ho fetisetsa motsoako (mohlala, li-tendon, ligaments le bone)
- liphatsa tsa lefutso (DNA) tsa phekolo (bona ka tlase *)
- lisebelisoa tsa lisele (sheba ka tlase *)
E 'ngoe le e' ngoe ea tsona e rekisoa tlas'a lebitso la lebitso le ka tsejoang haholo, joaloka Avastin, Herceptin, Enbrel, Epotin, Remicade, Humira kapa Avonex.
Li-Biologics Ha li na Tlhaloso e Hlakileng ea Boholo-holo
Ho fapana le lithethefatsi tse ngata tsa lik'hemik'hale, lik'hemik'hale tse ngata ha li na letho le hlalosoang ka mokhoa o ts'oanang le o tloaelehileng . The FDA e hlalosa generics e le se nang le sehlahisoa se tšoanang se mafolofolo e le letšoao la lebitso la lebitso. Hase feela hoo, empa hape ba bioequivalent - ba na le foromo e lekanang ea tekanyo, matla, boleng le tshebetso. Ho e-na le hoo, li-biologics li na le litsebi tsa lintho tse phelang, tse neng li hlalosoa ke molao ka 2009.
Li-biosimilars
Litsebi tsa likokoana-hloko ke lithethefatsi tse amoheloang ke FDA tse se nang likamano tse nang le moelelo ho tsoa ho lebitso la pele la biologic agent.
Li lokela ho ba tse sireletsehileng le tse sebetsang hantle 'me li sebetse ka tsela e tšoanang le sehlahisoa sa libuka. Sesebelisoa se bitsoa ho feto-fetoha ha se kopana le tekanyetso ea biosimilarity mme e lokela ho khona ho fetisetsoa ka sehlahisoa sa pele ntle le keketseho ea kotsing.
Molao o ngotsoeng oa meriana ea likokoana-hloko o ne o thibetsoe United States feela ho fihlela ha Molao oa Tlhokomelo oa Tlhokomelo o ka rekisoang ka 2010. Ho latela phetolelo ea Biologicals Price Competition le Innovation Act (BCPI) ea 2009 le Phallo ea Mokuli le Tlhokomelo e Ntle ea ho ea ka 2010, likokoana-hloko lihlahisoa li na le tsela e lumellanang le litente ka FDA.
Lithethefatsi tse ngata le tse ling tse fapanyetsanoang li tla fumaneha United States ka phetoho ena ea molao.
Pele ho 2009, lihlopha tse ngata li ile tsa itokisetsa ho khothaletsa FDA hore e qale ho lumella ho hlahisa lihlahisoa tsa tlhaho kapa liphetoho tsa li-biologics tsa khale e le tsela ea ho boloka chelete ea tsamaiso ea bophelo bo botle. Ka mohlala, lebitso la insulin le lihlahisoa tsa mofuta oa insulin li ka tsoa chelete ea $ 150 ho ea ho $ 1000 ka khoeli. Tsela e lekanang e latelang e reka chelete e ka bang $ 25 ka khoeli. Ha u atisetsoa ke palo ea batho ba hlokang mefuta ena ea phekolo, u ka bona kamoo tumello ea li-biologics tse latelang e ka bolokang tsamaiso ea libilione.
Lihlahisoa tse kholo tsa li-biologic li ikitlaetse khahlanong le tsoelo-pele le tlhahiso ea litsebi tsa liphoofolo hobane li ne li sa batle ho qabana le phekolo e theko e tlaase, empa e sebetsang (latela chelete). Ba qotsitse mathata a polokeho ts'ebetsong ea tsoelo-pele le ho hloka bopaki ba hore lithethefatsi tsena li tla sebetsa hantle joaloka li-original.
Mohloli
Tlhahisoleseding bakeng sa bareki (Li-Biosimilars) - Tsamaiso ea Lijo le Lithethefatsi tsa US 8/27/2015.