WHAT is the meaning of the term ‘biosimilar’?
The term ‘biosimilar’, ‘biosimilar medicine’ or ‘similar biological medicinal product’ (official legal term) is a term derived from the nature of the medicine and from the EU regulatory and legal route for approving these medicines. ‘Biosimilar’ denotes a biological medicine which is highly similar to an already authorised reference biological medicine. This term should only be used to describe follow-on biological medicines that have been approved following a rigorous comparability exercise as is required in the EU and other non-EU highly regulated markets. All biopharmaceuticals are inherently variable due to the fact that they are produced from living organisms. This variability exists within batches, from batch to batch, and when production processes are improved or changed or differ between manufacturers. The variability of biopharmaceuticals is greater than that typically observed for conventional pharmaceuticals and applies to originator reference products as well as biosimilars
