Biosimilar medicines: Overview
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.
EMA and the European Commission have developed information materials on biosimilar medicines to improve understanding of these medicines in the EU.
EMA's Chief Medical Officer, Steffen Thirstrup, explains what biosimilars are and how they work in the video below:
The video is also available in the following European languages: Czech (subtitles), Dutch, English, Estonian (subtitles), French, German, Italian, Polish, Portuguese, Slovenian (subtitles) and Spanish. EMA plans to publish further language versions when available.
An information guide for patients published by the European Commission explains in a clear, unbiased way what biosimilar medicines are, how they are developed and approved in the EU and what patients can expect in terms of availability and safety.
EMA and organisations representing patients contributed to the development of this guide.
It is available in 23 official EU languages on the Commission's website.
EU scientific experts and organisations representing doctors, nurses, pharmacists and patients contributed to the development of this guide.
This guide is also available in 23 official EU languages.
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.
EMA and the Heads of Medicines Agencies (HMA) have emphasised that biosimilars approved in the EU are interchangeable from a scientific viewpoint, meaning that a biosimilar can be used instead of its reference product, or vice versa.
A biosimilar can likewise be used in place of another biosimilar of the same reference product.
Any interchange should only take place after careful consideration of the product information.
EMA's Chief Medical Officer, Steffen Thirstrup, summarises the interchangeability of biosimilars in the video below:
EU Member States continue to decide which biological medicines are available for prescribing in their country and whether automatic substitution with biosimilars is allowed at pharmacy level.
The EMA / HMA statement aims to address any uncertainty among prescribers of biological medicines and support patient access to biosimilars for treating diseases such as cancer, diabetes and rheumatic diseases.
A 'questions and answers' document is available for healthcare professionals, patients and other stakeholders to further address issues related to the interchangeability of biosimilars in EU countries.
Overview of biosimilars approved in the EU
Patients and healthcare professionals with questions on practical aspects of biosimilar interchangeability should contact the national health authorities in their country:
EMA can help address questions on how biosimilars are approved and monitored in the EU:
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.
The safety of biosimilars is monitored through pharmacovigilance activities once they are on the market, in the same way as for other medicines.