Biosimilar medicines

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A similar biological or 'biosimilar' medicine is a biological medicine that is similar to another biological medicine that has already been authorised for use. Biological medicines are medicines that are made by or derived from a biological source, such as a bacterium or yeast. They can consist of relatively small molecules such as human insulin or erythropoietin, or complex molecules such as monoclonal antibodies.

Biosimilars can only be authorised for use once the period of data exclusivity on the original 'reference' biological medicine has expired. In general, this means that the biological reference medicine must have been authorised for at least 10 years before a similar biological medicine can be made available by another company.

Role of the European Medicines Agency

The Agency is responsible for assessing applications from companies to market biological medicines for use in the European Union (EU), including biosimilar medicines.

Requirements for authorisation of biosimilar medicines

For biosimilar medicines, the company needs to carry out studies to show that the medicine:

  • is similar to the reference medicine;
  • does not have any meaningful differences from the reference medicine in terms of quality, safety or efficacy.

As information on the reference medicine is already available, the amount of information on safety and efficacy needed to recommend a biosimilar for authorisation is usually less than the amount needed to authorise an original biological medicine.

As with all medicines, the Agency continues to monitor the safety of biosimilar medicines once they are on the market.

Documents of interest

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Document(s) Language Status First published Last updated Effective Date
Questions and answers on biosimilar medicines (similar biological medicinal products) BG = bălgarski   30/10/2008 28/09/2012  
Questions and answers on biosimilar medicines (similar biological medicinal products) ES = español   30/10/2008 28/09/2012  
Questions and answers on biosimilar medicines (similar biological medicinal products) CS = čeština   30/10/2008 28/09/2012  
Questions and answers on biosimilar medicines (similar biological medicinal products) DA = dansk   30/10/2008 28/09/2012  
Questions and answers on biosimilar medicines (similar biological medicinal products) DE = Deutsch   30/10/2008 28/09/2012  
Questions and answers on biosimilar medicines (similar biological medicinal products) ET = eesti keel   30/10/2008 28/09/2012  
Questions and answers on biosimilar medicines (similar biological medicinal products) EL = elliniká   30/10/2008 28/09/2012  
Questions and answers on biosimilar medicines (similar biological medicinal products) EN = English   30/10/2008 28/09/2012  
Questions and answers on biosimilar medicines (similar biological medicinal products) FR = français   30/10/2008 28/09/2012  
Questions and answers on biosimilar medicines (similar biological medicinal products) IT = italiano   30/10/2008 28/09/2012  
Questions and answers on biosimilar medicines (similar biological medicinal products) LV = latviešu valoda   30/10/2008 28/09/2012  
Questions and answers on biosimilar medicines (similar biological medicinal products) LT = lietuvių kalba   30/10/2008 28/09/2012  
Questions and answers on biosimilar medicines (similar biological medicinal products) HU = magyar   30/10/2008 28/09/2012  
Questions and answers on biosimilar medicines (similar biological medicinal products) MT = Malti   30/10/2008 28/09/2012  
Questions and answers on biosimilar medicines (similar biological medicinal products) NL = Nederlands   30/10/2008 28/09/2012  
Questions and answers on biosimilar medicines (similar biological medicinal products) PL = polski   30/10/2008 28/09/2012  
Questions and answers on biosimilar medicines (similar biological medicinal products) PT = português   30/10/2008 28/09/2012  
Questions and answers on biosimilar medicines (similar biological medicinal products) RO = română   30/10/2008 28/09/2012  
Questions and answers on biosimilar medicines (similar biological medicinal products) SK = slovenčina   30/10/2008 28/09/2012  
Questions and answers on biosimilar medicines (similar biological medicinal products) SL = slovenščina   30/10/2008 28/09/2012  
Questions and answers on biosimilar medicines (similar biological medicinal products) FI = suomi   30/10/2008 28/09/2012  
Questions and answers on biosimilar medicines (similar biological medicinal products) SV = svenska   30/10/2008 28/09/2012  
Questions and answers on biosimilar medicines (similar biological medicinal products) HR = Hrvatski   30/10/2008 28/09/2012  
Biosimilar medicinal products (English only)   29/03/2011 22/05/2013