Biosimilars: it's not as simple as cost alone

• Published in: Journal of clinical pharmacy and therapeutics Vol. 33; no. 5; pp. 459 - 464
• Main Authors: Roger, S. D., Goldsmith, D.
• Format: Journal Article
• Language: English
• Published: Oxford, UK Blackwell Publishing Ltd 01-10-2008
• Subjects: Biological Products - adverse effects; Biological Products - economics; Biological Products - pharmacokinetics; biopharmaceuticals; Biosimilars; Cost Savings; costs; Drug Approval - economics; Drug Approval - legislation & jurisprudence; Drug Costs; Drugs, Generic - adverse effects; Drugs, Generic - economics; Drugs, Generic - pharmacokinetics; Epoetin Alfa; Erythropoietin - administration & dosage; Erythropoietin - adverse effects; generics; Humans; Product Surveillance, Postmarketing - economics; Product Surveillance, Postmarketing - methods; Recombinant Proteins - adverse effects; Recombinant Proteins - economics; Recombinant Proteins - pharmacokinetics; Red-Cell Aplasia, Pure - etiology; safety; Therapeutic Equivalency
• ISSN: 0269-4727; 1365-2710
• DOI: 10.1111/j.1365-2710.2008.00942.x

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.