Biosimilar medicines

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A biosimilar is a biological medicine highly similar to another already approved biological medicine (the ‘reference medicine’). Biosimilars are approved according to the same standards of pharmaceutical quality, safety and efficacy that apply to all biological medicines. The European Medicines Agency (EMA) is responsible for evaluating the majority of applications to market biosimilars in the European Union (EU).

Biological medicines contain active substances from a biological source, such as living cells or organisms. 

Most biological medicines in current clinical use contain active substances made of proteins. These can differ in size and structural complexity, from simple proteins like insulin or growth hormone to more complex ones such as coagulation factors or monoclonal antibodies.

Often produced by cutting-edge biotechnology, biological medicines offer treatment options for patients with chronic and often disabling conditions such as diabetes, autoimmune diseases and cancers.

The EU has pioneered the regulation of biosimilar medicines by establishing a solid framework for their approval and by shaping biosimilar development globally. 

The evidence acquired over 10 years of clinical experience shows that biosimilars approved through EMA can be used as safely and effectively in all their approved indications as other biological medicines.

For the list of biosimilar medicines approved via the Agency, see:

Information guide for healthcare professionals

Leaflet_biosimilars_thumbnailEMA and the European Commission have published an information guide for healthcare professionals to provide them with reference information on the science and regulation underpinning the use of biosimilar medicines.

EU scientific experts and organisations representing doctors, nurses, pharmacists and patients contributed to the development of this guide.

Biosimilar development and approval in the EU

EMA is responsible for evaluating all applications to market biological medicines produced using biotechnology, including the majority of biosimilar medicines, before they can be approved and marketed in the EU.

EMA's scientific committees evaluate the marketing authorisation applications, with support from the Biologics Working Party and the Biosimilars Working Party.

Developers of biosimilars are required to demonstrate through comprehensive comparability studies with the 'reference' biological medicine that:

  • their biological medicine is highly similar to the reference medicine notwithstanding natural variability inherent to all biological medicines;
  • there are no clinically meaningful differences between the biosimilar and the reference medicine in terms of safety, quality and efficacy.

By demonstrating biosimilarity, a biosimilar can rely on the safety and efficacy experience gained with the reference medicine. Biosimilarity means high similarity in terms of structure, biological activity and efficacy, safety and immunogenicity profile.

This allows avoiding the unnecessary repetition of clinical trials already carried out with the reference medicine.

Biosimilars can only be authorised for use once the period of data exclusivity on the '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.

Regulatory guidance

EMA has published scientific guidelines to help developers of biosimilar medicines conform to the strict regulatory requirements for approving biosimilars.

Applicants preparing to request marketing authorisation for a biosimilar medicine via EMA should follow the Agency's procedural advice for the centralised authorisation of biosimilar medicines.

The safety of biosimilars is monitored through pharmacovigilance activities once they are on the market, in the same way as for any other medicine.

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