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.
- Biosimilar medicines authorised via the Agency (opens in new window)
Tailored scientific advice pilot project (new)
EMA will launch a tailored scientific advice pilot project in February 2017 to support the development of new biosimilars.
The tailored procedure will advise developers on the studies they should conduct, based on a review of the quality, analytical and functional data they already have available. Standard scientific advice does not include the assessment of existing data.
The pilot is open to all types of biosimilars and includes a pre-submission meeting to review the suitability of the data package. Applicants should note that EMA’s Scientific Advice Working Party will need an extra month in addition to normal scientific advice timelines to review applications.
EMA plans to run the pilot until it has completed six scientific advice requests, with maximum one scientific advice request accepted per month. The Agency will analyse the outcome after completing the pilot.
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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.