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 offer treatment options for patients with chronic and often disabling conditions such as diabetes, autoimmune disease and cancers.

Biological medicines contain active substances from a biological source, such as living cells or organisms (human, animals and microorganisms such as bacteria or yeast) and are often produced by cutting-edge technology.

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.

Examples of types of proteins in biological medicines approved in the EU

A biosimilar is a biological medicine highly similar to another biological medicine already approved in the EU (called ‘reference medicine’) in terms of structure, biological activity and efficacy, safety and immunogenicity profile (the intrinsic ability of proteins and other biological medicines to cause an immune response). 

The EU approved the first biosimilar in 2006.

A biosimilar is not regarded as a generic of a biological medicine. This is mostly because the natural variability and more complex manufacturing of biological medicines do not allow an exact replication of the molecular micro-heterogeneity.

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 ten 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 a list of biosimilar medicines approved via the centralised procedure, see:

The Commission has published an information guide for patientson biosimilar medicines. The Commission, the EMA and organisations representing patients contributed to the development of this guide.

EMA 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’s scientific committees evaluate the majority of marketing authorisation applications for biosimilar medicines before they can be approved and marketed in the EU.

EMA evaluates biosimilars according to the same standards of pharmaceutical quality, safety and efficacy that apply to all biological medicines approved in the EU.

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.

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

Biosimilar competition should improve patient access to safe and effective biological medicines with proven quality.

Comparison of data requirements for approval of a biosimilar versus the reference medicine

Biosimilars can only be authorised 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 eight years before another company can apply for approval of a similar biological medicine.

Regulatory guidance

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

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Leaflet: What I need to know about biosimilar medicines - information for patients

Leaflet: Biosimilars in the EU - information guide for healthcare professionals

Leaflet biosimilars

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