Biotechnology has been widely adopted by industrials in the development of new drugs, and they represent a growing share of all drugs worldwide. For years, the production of these medicines was considered too complicated to allow for the development of non-innovator versions. However, since early 2000, biosimilars have been granted market access in the European Union.
A biosimilar is a biological medicinal product that contains a version of the active substance of an already authorized original biological medicinal product (reference medicinal product). Similarity to the reference medicinal product in terms of quality characteristics, biological activity, safety and efficacy based on a comprehensive comparability exercise needs to be established.
Importance of biosimilars
Considering the increase in costs of pharmaceuticals assorted to the current health budget constraints, biosimilars represent a promising option to reduce pharmaceutical expenditures and/or increase patients' access to biologicals in European countries. However, issues like substitution, incentives for prescribers, etc. exist today and have to be tackled in order that biosimilars are used to their maximum potential.