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 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.


RESULTS
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.
Department of Renal Medicine, Gosford Hospital, Gosford 2250, Australia. sroger@nsccahs.health.nsw.gov.au
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D001688:Biological Products / Q000009:adverse effects / Q000191:economics / Q000493:pharmacokinetics*; D017046:Cost Savings; D017277:Drug Approval / Q000191:economics / Q000331:legislation & jurisprudence; D016527:Drug Costs; D016568:Drugs, Generic / Q000009:adverse effects / Q000191:economics / Q000493:pharmacokinetics*; D000068817:Epoetin Alfa; D004921:Erythropoietin / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D011358:Product Surveillance, Postmarketing / Q000191:economics / Q000379:methods; D011994:Recombinant Proteins / Q000009:adverse effects / Q000191:economics / Q000493:pharmacokinetics*; D012010:Red-Cell Aplasia, Pure / Q000209:etiology; D013810:Therapeutic Equivalency
D001688:Biological Products; D016568:Drugs, Generic; D011994:Recombinant Proteins; D004921:Erythropoietin; D000068817:Epoetin Alfa