To market a pharmaceutical product, manufacturers need to perform a head-to-head comparison with its original counterpart, the Reference Medicinal products (RMP) / Reference Listed Drugs (RLDs). This process, called a Comparability Exercise, aims to highlight both the similarities between generic or biosimilar and the reference products, as well as the variations in their manufacturing processes. This is a necessary procedure to obtain authorization from regulatory bodies such as EMA (European Medicines Agency) and FDA (Food and Drug Administration) to produce a generic drug or biosimilar within a given range of variation.
However, such a task requires highly specialized sourcing capabilities to provide enough batches of the reference molecule to fully appreciate these differences.
Reference Listed Drugs
The novel drug used to compare against when developing generic equivalents to branded products. Often the RLD is the first approved, or the industry treatment norm, and is used to set a baseline of treatment efficacy.
An approved medication that is utilized in a clinical trial to compare the efficacy of an investigational drug to the efficacy of a standard of care treatment. A comparator can be used instead of a placebo, or in conjunction with a placebo.