Biosimilar medicines: marketing authorisation

A biosimilar is biological medicine highly similar to another already approved biological medicine in the European Union (EU), for which marketing exclusivity rights have expired. The European Medicines Agency (EMA) is responsible for evaluating the majority of applications to market biosimilar medicines before they can be approved and marketed 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.

Biosimilar development relies heavily on comparability studies to establish similarity to the reference product. This involves a comprehensive head-to-head comparison of the biosimilar and the reference medicine.

Comparability is conceived as a step-wise process that is tailor-made for each product. Knowledge of the initial quality comparability studies is used to determine the extent and type of non-clinical and clinical studies required in the next step of development, always with the aim of ruling out differences in clinical performance between the biosimilar and the reference medicine.

Biosimilar development

Infographic - Biosimilars development comparative studies

Scientific guidelines

The European Medicines Agency has developed scientific guidelines on biosimilar medicinal products to help medicine developers prepare marketing authorisation applications for human medicines.

Tailored scientific advice pilot project

EMA launched a tailored scientific advice pilot project in February 2017 to support the development of new biosimilars.

The tailored procedure advises developers on the studies they should conduct, based on a review of the quality, analytical and functional data they already have available.

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.

For more information:

Procedural advice

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

EMA has published questions and answers (Q&As) on its position on issues applicants preparing to request marketing authorisation for a biosimilar medicine typically raise. This complements the Agency's pre-authorisation guidance.

EMA updates these Q&As regularly to reflect new developments, to include guidance on further pre-authorisation procedures and to reflect the implementation of new European legislation. Revised topics are marked 'New' or 'Rev.' on publication.

These Q&As provide guidance only and should be read in conjunction with the rules governing medicinal products in the European Union, volume 2, notice to applicants.

Marketing authorisation holders must in all cases comply with the requirements of Community legislation. Provisions that extend to Iceland, Liechtenstein and Norway by virtue of the European Economic Area agreement are outlined in the relevant sections of the text.

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

PDF versions of Q&As

1. Eligibility and reference product

2. Steps prior to submitting the application

3. Assessment of the application

4. Post-authorisation


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