FDA waxay soo saartay Nidaamka Cusub ee lagu ogalaanayo Biosimilars
Waa maxay Biologics?
Biyoolojiyada intooda badani waa kuwo aad u ballaaran, maadooyin adag ama isku dhafka maaddooyinka, oo loo isticmaalo daweynta kansarka, Cudurka Alzheimers, sclerosis badan, HIV / AIDS iyo cudurrada kale ee daran.
Cilmi-nafsiyaadka Qiimeeynta iyo Sharciga Cusub
Oggolaanshaha biosimilar waxay kaa caawin kartaa badbaadinta kharashka. Daaweynta daawooyinka bayoolojiga ah waxay kharashka bukaanka iyo shirkadaha caymiska ku kici karaan meel kasta oo ka kacda $ 100,000 ilaa $ 300,000 sannadkii. Ururka Pharmaceutical Association (GPhA) ayaa sheegay in caddeymo ka yimid dhowr daraasadood oo muujinaya in soo galitaanka korodhka biosimilada ee suuqa ay ku badbaadin karaan $ 42 bilyan ilaa $ 108 billion muddo 10 sano ah.
Madaxweyne Obama wuxuu saxiixay Sharciga Daryeelka Bukaanka iyo Sharciga Daryeelka La Yiqhi Karin ee Sharciga ee 2010, iyo dariiq loo soo gaabiyo si loogu ansixiyo baasiino-bi'iya ayaa loo ansixiyey iyada oo qayb ka ah sharcigaas. Sida ku cad Sharciga Kharashka Qiimeynta Bayaanka iyo Heshiiska Cusub (BPCIA), badeecada bayoolojiga ah ayaa loo go'aamin karaa biosimilar haddii xogtu muujiso in ay aad u la mid tahay daawada biologiska ee hore loo ansixiyay.
Badeecada biosimilar waa inay lahaataa heerarka isbarbardhigga ah ee waxtarka iyo nabadgelyada wax soo saarka asalka ah in loo oggolaado jadwalka saacadaha la dedejiyey; farqiga keliya ee la oggol yahay waa ku jiraan maaddooyinka aan firfircooneyn ama qaybaha.
Baaskiilada ugu horeysay ee la ansixiyey
FDA waxay ansixisay badeecada ugu horeysa ee biosimilar ee Mareykanka bishii Maarso ee sannadka 2015: Zarxio. Zarxio wuxuu ahaa biosimilar ah Neupogen, daawo lagu tilmaamay daaweynta bukaanka:
- Kansarka waxaa la siiyaa kiimiko daaweynta myelosuppressive
- Iyadoo la yiraahdo 'myeloid leukemia' oo qaata kiimikada daaweynta indhaha ama isugeynta
- Kansarka qaliinka lafo-beelka laf dhabarta
- Qaadashada unugyada dhiig-yare ee unugyada dhiig-yare ee unugyada dhiig-miiraanka iyo daaweynta
- Ayadoo la raacayo neutropenia raagay oo daran.
Saameyn ku yeelashada warshadaha
Badeecada loo yaqaan 'biosimilar' ayaa looga shakisan yahay inay sii wadi karto saamaynta weyn ee warshadaha dawada ee Maraykanka iyo Yurub. Sababtoo ah tartame la kordhiyey iyadoo la raacayo dardargelinta degdega ah ee biosimilar iyo horudhaca degdegga ah ee suuqa, xaaladaha suuqyada ayaa loo baahan yahay in ay isbeddelaan. Ma aha oo kaliya bukaanlayda ayaa leh fursado daaweyneed oo dheeraad ah, laakiin waxay sidoo kale awood u leeyihiin inay helaan daawooyinka ay u baahan yihiin khatarta daran ee kharashyada ka hooseeya khudradda asalka ah. Iyada oo ay biosimilaradu noqdaan kuwo si ballaaran loo heli karo, macaamiisha ayaa filan kara waxtarka, amniga iyo kalsoonida sida daawada asalka ah qiimaha jaban.
Oggolaanshaha FDA ee ku saabsan waqtiga loo dedejiyey ee biosimilars waxay muujinaysaa isbedelka warshadaha iyo kartida dhibco daran oo faa'iido u leh shirkadaha dawooyinka. Tani waa fursad loogu talagalay ururada ku takhasusay jeneriga iyo biosimilar si ay si dhaqso ah ugu koraan ganacsigooda.
Shirkadaha sida Coherus, Teva iyo Sandoz ayaa la rajeynayaa inay muujiyaan koror weyn oo ah tobanka sano ee soo socda maaddaama ay keenaan badeecooyin badan oo biosimilar ah oo suuqa ah.
Tani waa suuqa oo sii wadi doona feejignaanta wershaddan billaha ah ee dollarka iyada oo suurtagal ah in la badalo warshadaha weligood.