I-FDA iye yaqalisa inkqubo entsha yokuvunyelwa kwee-Biosimilars
Ziziphi Izinto Zezinto Eziphilayo?
Ininzi i-biologics inkulu kakhulu, i-molecule ezinzima okanye i-mix of molecules, esetyenziselwa ukunyanga umdlavuza, isifo se-Alzheimer, i-multiple sclerosis, i-HIV / AIDS nezinye izifo ezinzulu.
UMthetho woPhuculo lweMveli kunye neNewnovation
Ukuvunyelwa kwee-biosimilars kunokukunceda ukugcina iindleko. Unyango kunye neziyobisi ze-biologic ziyakhathaza izigulane kunye neenkampani zomshuwalense ukusuka kwi $ 100,000 ukuya kwii-300,000 zamawaka ngonyaka. I-Generic Pharmaceutical Association (GPhA) ithi ubungqina obuvela kwizifundo eziliqela lubonisa ukuba ukungena kwenyuka kwama-biosimilars kwimarike kunokugcina i-$ 42 billion ukuya kwi-108 yezigidigidi kwi-10 iminyaka.
UMongameli uBrazil wasayina iSiqinisekiso soKhuseleko kunye noMthetho woNonophelo oNgenakunqwenelekayo ngomthetho ngowama-2010, kwaye umendo ogqityiweyo wokuvunyelwa kwezinto ezifunyenwe yi-biosimilars uvunyiwe njengenxalenye yalo mthetho. Ngaphantsi koMthetho we-Biologics Price Competition and Innovation Act (BPCIA), umkhiqizo wezinto eziphilayo unokumiselwa ukuba ube yi-biosimilar ukuba idatha ibonisa ukuba iyafana kakhulu neyeza ezivunyiweyo ze-biologic.
Imveliso ye-biosimilar kufuneka ibe namazinga afanelekileyo okusebenza kunye nokukhusela kwimveliso yokuqala eya kuvunywa kwixesha elikhawulezileyo; Ukwahlukana okuvunyelwe kuphela kwiimveliso ezingekhoyo zokusebenza okanye izinto.
I-Biosimilars yokuqala ivunyiwe
I-FDA ivume imveliso yokuqala ye-biosimilar e-United States ngo-Matshi ka-2015: i-Zarxio. I-Zarxio yayiyi-biosimilar ku-Neupogen, unyango oluboniswe unyango lwezigulane:
- Unomdla wokufumana i-myelosuppressive chemotherapy
- I-leukemia enesifo esichukumisayo sokufumana i-chemotherapy
- Ngomdlavuza ophantsi kokutsalwa komnatha we-bone
- Ukuhamba kwegazi kunye ne-antilogologic blood cell
- Nge-neutropenia engapheliyo.
Impembelelo kumashishini
Iimveliso ze-Biosimilar zikhankanywa ukuba ziyaqhubeka zineempembelelo ezibonakalayo kwi- shishini lezobisi kwi-US naseYurophu. Ngenxa yokunyusa ukhuphiswano kunye nokuvunywa okukhawulezileyo kwezinto eziphilayo kunye nokusungulwa kwazo ngokukhawuleza kwiimarike, iimeko zemarike ziya kuguqulwa ukulungelelanisa. Akunjalo kuphela izigulane zinokukhetha unyango olungaphezulu, kodwa ziya kuba nakho ukufumana amayeza abayidingayo ngenxa yokukhathazeka okukhulu kwiindleko eziphantsi kakhulu kunezinto eziphilayo zakuqala. Ngezinto eziphilayo zifumaneka ngokubanzi, abathengi banokulindela ukuphumelela, ukukhuselwa nokuthembeka okufana neyeza lokuqala kwixabiso elincinci.
Ukuvunyelwa kwe-FDA yexesha elikhawulezileyo leempawu ze-biosimilars zitshintsha utshintsho kwi-shishini kunye nokwenzeka kwamanxuwa amaninzi kwiingeniso kwiinkampani zonyango. Leli thuba lemibutho echanekileyo kwii-generics kunye ne-biosimilars ukwenzela ukukhula kwamashishini abo ngokukhawuleza.
Iinkampani ezinjengeCoherus, iTeva ne-Sandoz zilindeleke ukuba zibonise ukukhula okukhulu kwiinyanga ezizayo njengoko zizisa iimveliso ze-biosimilar ukuthengisa.
Le yimarike eya kuhlala igxininise kule shishini-mali yeebhiliyoni kunye nokukwazi ukuguqula umboniso ngonaphakade.