Iyo FDA Yakatanga Nzira Itsva Yokubvumirwa kweBhiosimilar
Chii Chinonzi Biologics?
Zvizhinji zvebiologics zvakakura kwazvo, zvinorema mamolekemu kana mishonga yemamolekoro, yakashandiswa kurapa kenza, chirwere cheAlzheimer, multiple sclerosis, HIV / AIDS nezvimwe zvirwere zvakakomba.
Biologics Price Competition uye Innovation Act
Kubvumirwa kwezvinhu zvinogona kubatsira kubatsira kuchengetedza mari. Kurapa nemishonga inonzi biologic kunogona kukonzera varwere nemakambani einishuwarenzi kupi zvako kubva pa $ 100,000 kusvika ku $ 300,000 pagore. Iyo Generic Pharmaceutical Association (GPhA) inoti humwe uchapupu hunobva kuongororo dzakawanda hunoratidza kuti kuwedzera kuwedzerwa kwezvinyorwa mumisika kunogona kuchengetedza $ 42 mabhiriyoni kusvika $ 108 mabhiriyoni pane makore gumi.
Mutungamiri Obama akanyora Chirwere Chekuchengetedza uye Affordable Care Act mutemo muna 2010, uye nzira yakafukidzirwa yekubvumirwa kwezvinyorwa zvechimiro yakagamuchirwa sechikamu chemutemo iwoyo. Pasi peBhiologics Price Competition uye Innovation Act (BPCIA), chigadzirwa chezvisikwa chinogona kutsungirirwa kuva biosimilar kana deta ichiratidza kuti yakangofanana neyakatenderwa mishonga ye biologic.
Bhiosimilar chigadzirwa chinofanira kunge chakafanana nehutano hwekushanda nekuchengeteka kune chigadzirwa chepakutanga chinogamuchirwa pane imwe nguva inowedzera; izvo chete zvakasiyana zvinobvumirwa zviri mune zvisiri izvo zvinoshanda zvinoshandiswa kana zvikamu.
Vokutanga Biosimilars Yakagamuchirwa
IA FDA yakagamuchira chigadzirwa chekutanga chebiosimilar muUnited States munaMarch 2015: Zarxio. Zarxio yaiva biosimilar kuNeupogen, mushonga wakaratidzwa mukurapa varwere:
- Nekenza inogamuchira myelosuppressive chemotherapy
- Nechirwere chinokonzera myeloid yeukemia yakagadziriswa kana kuwedzerwa chemotherapy
- Ane kenza inopfurikidza nemapfupa ekutengesa
- Inotenderera kune autologous peripheral ropa progenitor cell collect collection uye therapy
- Nechirwere chisingaperi chineutropenia.
Migumisiro paIkambani
Biosimilar michina inofungidzirwa kuti inoramba ichinyanya kukosha kumashandisi emishonga muU.S. uye muEurope. Pamusana pekukwikwidzana nekukwiridzirwa kwepamusoro kwehupenyu hwevanhu uye kushandiswa kwavo nokukurumidza kumusika, mamiriro ezvinhu emisika achafanira kuchinja kuchinja. Kwete chete varwere vane mamwe maitiro ekurapa, asi ivo vanogonawo kuva nekwaniso yekuwana mishonga yavanoda nokuda kwezvinetso zvakakomba pane mari shoma shoma pane yepakutanga biologics. Nezvinyorwa zvehupenyu zvikava zvakanyanya kupararira, vatengi vanogona kutarisira kushanda kwakadaro, kuchengeteka nekuvimbika semishonga yekutanga pamutengo wakaderedzwa.
Kubvumirwa kwaDAA kwekuwedzerwa kwemazuva ekugadzirisa zviratidzo zvinoshandiswa pakuchinja mune zvemabhizimisi uye zvinogona kuita madonhwe makuru muzvikwereti kumakambani emishonga. Uyu mukana wemasangano anonyanya kugadzirwa nemagetsi uye maitiro ekuraira mabhizinesi avo nokukurumidza.
Makambani akafanana neCherus, Teva neSandoz anotarisirwa kuratidzira huwandu hwekuwedzera mumakore gumi anotevera sezvo vachiunza zvinhu zvakawanda zvebiosimilar kutengesa.
Uyu ndiwo mushamba ucharamba uchitarisa mune ino mabhizimusi-madhora emadhora uye mukana wokushandura iyo indasitiri nekusingaperi.