TableĀ 1

Exclusion criteria and rationale

Exclusion criteriaRationale
Generic drugsLicensed on the basis of similarity to existing drugs and would result in duplication
Biosimilar drugsThe interpretation of data from trials of biosimilars is likely to be informed by data available regarding the original drug (in mechanism and effect on a condition). As such biosimilar applications cannot be considered as comparable to applications for new drugs for which no external information is available
Diagnostic technologies and medical devicesAs there is no therapeutic effect to measure, these are assessed by different criteria
VaccinesThe majority of vaccines are licensed based on well-understood technologies and mechanisms of action and it is therefore to consider their use in isolation
Antimicrobial productsThe approval process for antimicrobial products involves different standards, with in vitro demonstrations of efficacy against different bacteria playing a much larger role in the expansion of indications
Blood products and recombinant blood productsIf identical to human blood products, the mechanism of action for these products is well understood, and thus the same efficacy trials to prove the concept of the intervention is not needed
Fixed dose combinations of existing productsUnless additional claims are made of the combination product, the evidence base for these products is influenced by that for the original products