Information to biosimilars: regulatory, licensing, pharmacovigilance, national and EU situation
A 'biosimilar' medicine is a biological medicinal product that is similar to an already authorised original biological medicinal product (reference medicinal product) in the European Economic Area (EEA). Biological medicines are made by a biological source, such as a bacterium or yeast, or isolated from a biological organism, e.g. the human body or an animal.
Comparability between the reference and the biosimilar medicinal product is the core principle of a biosimilar development. 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 in a stepwise approach.
• First step - quality comparability (comparability of the physicochemical characteristics and biological activity)
• Second step - non-clinical comparability (comparative non-clinical studies)
• Third step - clinical comparability (comparative clinical studies)
A biosimilar medicinal product and its reference medicinal product are expected to have highly comparable safety and efficacy profiles and are generally used to treat the same conditions. As information on the safety and efficacy of the reference medicine is already available, the amount of information needed for authorisation of a biosimilar is usually less than the amount needed for approval of an original biological medicine.
Biosimilars can only be authorised for use once the period of data exclusivity on the original 'reference' biological medicine has expired.
Further information on biosimilars can be found on the European Medicines Agency (EMA) website: www.ema.europa.eu/ema/index.jsp
The Consensus Information Document 2013 “What you Need to Know about Biosimilar Medicinal Products” published on the European Commission website addresses frequently asked questions (including Q&A for patients and physicians):
For scientific guidelines on biosimilar medicines follow the link:
For a list of biosimilar medicines approved by the EMA and further information on these products:
Created: 26.11.2014 | Page last modified: 23.01.2015