What is a biosimilar medicine?

Biosimilar medicines are follow-on versions of original biological medicines. Biosimilars can be developed during the period in which the originator product is  protected by patent exclusivity, but they can only be marketed after the patent protecting the originator product has expired.

Biosimilar medicines are independently developed to have the same mechanism of action as the original biological medicines, and are designed to treat the same diseases as the innovator’s product.

For further information about biosimilars please see the European Commission Consensus Paper “What you need to know about Biosimilar Medicinal Products, which is available in EnglishGermanFrenchSpanishItalianPortuguese.

For further information on the EuropaBio policy position on Biosimilars - specifically about our views on naming, labelling and terms of use of biosimilars - please refer to our Guide on Biosimilars in Europe and our Position Paper.

Latest Faq