Where does the word “biosimilar” come from?
Innovative medicines generally benefit from a certain period of intellectual property protection via patents and other exclusive rights such as data protection and market exclusivity.
Patent rights give the patent holder (often, but not always, the manufacturer), the right to prevent others from manufacturing, selling, using and importing a product, or using a process or selling a product made by that process during a limited period of time, e.g. 20 years from the date of application.
Data and market exclusivity mean that there is a period of time after approval before a competitor can enter the market with a follow-on product that relies wholly or partly on the originator’s data on safety and efficacy for its regulatory approval. The follow-on product can often use an abbreviated regulatory approval procedure.
Follow-on versions of chemical medicines that enter the market after expiry of IP protection are called “generics”. Follow-on versions of biological medicines are called “similar biological medicinal products” or “biosimilars”. In both cases, the originator product is called the “reference product”.
For further information please see our publication about Biosimilar Medicines