Biologics, inozivikanwawo semishonga yemagetsi kana biologic agents, kuongororwa, kudzivirira, uye kurapwa kwakagadzirwa uye kunogadzirwa kuburikidza nehutano hwehupenyu kuburikidza nevanhu, mhuka kana michina inowanikwa. Izvi zvakasiyana nemishonga yemishonga, iyo inogadzirwa kubva kumakemikari maitiro.
Kune nhamba ipi zvayo yezvinhu zvakabva kuvanhu, mhuka kana zvipembenene zvinoshandiswa mune zvigadzirwa zvehupenyu, zvakadai seshuga, mapuroteni, nucleic acids, masero, ropa kana tishu.
Kushandisa biotechnology, zvinosanganiswa kana kushandiswa kugadzira zvinhu zvingatibatsira kuongorora , kubata, kutarisira, kana kurapa zvirwere nemamiriro.
Pakati pezvokutanga zvipenyu zvinonzi insulin , iyo yakave yakagadzirwa kubva pamhuka. Mazuva ano zvakagadzirwa ne insulin zvinowanzova mugumisiro weDNA recombinant, nzira yakasiyana, asi zvichiri biologic mumasikirwo.
Mishonga ndeye biologics iyo yave iripo kwemazana emakore. Zvinoshandiswa kushandisa chikamu chetachiona kana mabhakitiriya anokonzera chirwere chiri kudziviswa. Izvi zvinogona kuurayiwa kana kunyorohwa kwechirwere, kana kuti inogona kunge iri proteiniti yakanatswa, shuga kana chimwe chikamu chemukoko.
Nokuisa pachena munhu pane izvi kugadziriswa kwakaitwa kubva kuhutachiona kana mabhakitiriya ari mubvunzo vasati vakura, muviri unoita nekuvaka zvirwere zvinorwisana nechirwere ichocho. Gare gare, kana akazarurirwa, murwere haazogadziri chirwere chacho.
Izvo zvinoshandiswa zvose zvipenyu.
Mimwe miedzo yakajairika uye kurapa ndeyezvakaberekwa, zvakare. Zvishandiso zveRopa zvinoshandiswa kuwedzerwa ropa , zvirwere zvakawanda zvekurwisa zvirwere uye shots, mishonga yemishonga yakadai seyo inoshandiswa kurarama zviratidzo zvekuenda kumwedzi, uye stem masayenzi emishonga anoshandiswa pakugadziriswa kana kukurudzirwa kwevamwe biologic agents inonzi inonzi biologics.
Rwendo rweBhiologics
Yakabatanidzwa kubva kune dzakawanda zvezviwanikwa, heino nyanzvi yemhando ye biologics:
- vaccines
- insulins
- interleukins
- human growth hormones
- hormone therapies, zvakadai sokushandiswa kweesrogen kana testosterone
- kuongororwa kunoratidzira vanhu vanogona kuisira ropa vane HIV kana zvimwe zvinotapukira
- ropa uye zvigadzirwa zveropa nekuda kwekuwedzerwa ropa
- ropa uye midziyo yeropa inoshandiswa mukugadzira nemimwe michina
- biologicalic extracts inoshandiswa kukura zvose zvirwere zvezveruzhinji uye zvinokonzera kupisa
- masero evanhu uye masukisi anoshandiswa pakutsvaga (somuenzaniso, tendon, ligaments, uye bone)
- gene (DNA) therapies (ona pasi apa *)
- cell therapies (ona pasi apa *)
Chimwe nechimwe chezvinhu izvi chinotengeswa pasi pezita rezita iro rinogona kuve rakajeka, saAvastin, Herceptin, Enbrel, Epotin, Remicade, Humira kana Avonex.
Biologics Haana Kunyatsotsanangurwa Maitiro Akafanana
Kusiyana nemakore akakura emakemikari madhiragi, mamwe biologics haaine izvo zvakanyatsorondedzerwa sezvakawanda zvakaenzana . I-FDA inotsanangura ma generics seine zvakanyatsoshanda izvo zvinoshandiswa sezita remishonga. Kwete izvozvo chete, asi ivowo vane bioequivalent - vane fomu imwechete yeiyo, simba, unhu, nekushanda. Pane kudaro, biologics ine biosimilars, iyo yakatsanangurwa nemutemo muna 2009.
Biosimilars
Biosimilars mishonga inogamuchirwa neRDA iyo isina maitiro ekugadzirisa zvakananga kubva kune zita rekutanga rainzi biologic agent.
Vanofanira kuva vakachengeteka uye vanobudirira uye vanoshanda nenzira imwecheteyo seyakanyorwa. Mishonga inonzi inoshandurana kana ikasangana nehuwandu hwebiosimilarity uye inofanirwa kuchinjwa nemuchero wepakutanga usina kuwedzera pangozi.
Chirongwa chemishonga yebiosimilar chakanga chakarehwa muUnited States kusvika pakupfuura kweChipatara Chine Mutemo Wechirongwa wegore ra2012. Nechikamu cheBioologicals Price Competition uye Innovation Act (BCPI) ya2009 uye Murwere Kudzivirira uye Affordable Care Act we 2010, biological mishonga ine nzira yakagadziriswa yekugadzirisa nzira kuburikidza neCDA.
Zvimwe zvinodhaka uye zvinodhindurudza zvinodhaka zvichawanikwa muUnited States nekuchinja uku mumutemo.
Kusati kwa2009, mapoka akawanda akakumbira kukurudzira FDA kutanga kutendera kugadzirwa kwezvigadzirwa zvezvinhu kana kushandiswa kwezvinyorwa zvekare zvechi biological semhando yekuchengetedza hurongwa hwehutano hwehutano. Semuenzaniso, mazita e-insulin uye zvakagadzirwa ne-insulin zvinodhura kubva pa $ 150 kusvika ku $ 1000 pamwedzi. Mutevedzeri unofanana unogona kudhura $ 25 chete pamwedzi. Kana ichiwedzerwa nehuwandu hwevanhu vanoda mhando idzi dzemishonga, unogona kuona kuti kugamuchirwa kweizvi kutevedza biologics kunogona kuchengetedza maitiro mabhiriyoni.
Vakakura biologic vaiti vakashandura kukurudzirwa nekugadzirwa kwemhando dzezvinhu nokuti havana kuda kuwirirana nemishonga shoma, asi inobudirira (tevera mari). Vakatsanangura zvinetso zvekuchengetedza muhutano hwekuvandudza nekushayikwa kwekuti mishonga iyi inogona kunge yakaita seyakatanga.
Chinhu
Mashoko kune Vashandi (Biosimilars) - US Food and Drug Administration 8/27/2015.