A biosimilar medicine is a medicine developed to be similar to an existing biological medicine. Unlike generic medicines which are considered identical to their reference medicine, biologic medicines cannot be reproduced exactly due to the complex nature of the production methods and molecular structure.
To gain marketing authorisation biosimilar medicines have to demonstrate that they are as safe and as effective as the original reference medicine and are of the same quality.
One Wales interim decisions which refer to a biological medicine will also apply to relevant biosimilar products which may appear on the market subsequent to publication of the decision provided that the biosimilar has an equivalent or lower net price when compared to the reference product.
Due to the small differences between biosimilars and/or the reference products biologic medicines should be prescribed by brand name to avoid automatic substitution and therefore help with pharmacovigilance.