Biosimilars: it's not as simple as cost alone.
Background: Biosimilars or follow-on biologics (FoB) are biopharmaceuticals that, unlike small molecule generic products, are copies of larger, much more complex proteins. As such, data generated from one biopharmaceutical cannot be extrapolated to another. Unlike small molecule generics, FoB requir...
| Publicado en: | Journal of Clinical Pharmacy & Therapeutics Vol. 33; no. 5; pp. 459 - 465 |
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| Autores principales: | , |
| Formato: | tables/charts Journal Article |
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Wiley-Blackwell
Oct2008
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=105588322&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 105588322 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 02694727 EV4 jtl: Journal of Clinical Pharmacy & Therapeutics issn: 02694727 maglogo: Y pubinfo: dt: Oct2008 vid: 33 iid: 5 pid: 480 pub: Wiley-Blackwell place: Malden, Massachusetts artinfo: ui: 105588322 105588322 2010123058 10.1111/j.1365-2710.2008.00942.x NLM18834359 105588322 ppf: 459 ppct: 6 formats: fmt: @attributes: type: P tig: atl: Biosimilars: it's not as simple as cost alone. aug: au: Roger SD Goldsmith D affil: Department of Renal Medicine, Gosford Hospital, Gosford 2250, Australia sug: subj: Biological Products Cost Savings Drugs, Generic Patient Safety Drug Design Economics, Pharmaceutical Legislation, Drug United Kingdom ab: Background: Biosimilars or follow-on biologics (FoB) are biopharmaceuticals that, unlike small molecule generic products, are copies of larger, much more complex proteins. As such, data generated from one biopharmaceutical cannot be extrapolated to another. Unlike small molecule generics, FoB require a full developmental programme, albeit smaller than for an originator product. This has been recognized by European regulatory authorities and it is becoming clear that accelerated processes for FoB marketing approval are not feasible. Objective: To determine the balance between costs surrounding FoB (including relatively extensive developmental programmes and subsequent price to the market) and the necessity to ensure efficacy and safety. Principal findings: It is important that FoB are sufficiently tested to ensure patient safety is not compromised. Conducting such a development programme followed by sound pharmacovigilance is very challenging and costly. Conclusions: Cost-savings associated with FoB may be limited. pubtype: Academic Journal doctype: tables/charts Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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