Similar-biological-medicine applications: questions and answers

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This section of the website contains questions that marketing-authorisation holders (MAHs) may have on similar-biological (biosimilar) medicine applications. It provides an overview of the European Medicines Agency's position on issues that are typically addressed in discussions or meetings with MAHs.

It complements existing guidance documents on innovative products and should be read in conjunction with the Agency's scientific guidelines on biosimilar medicines.

The questions and answers are updated regularly to reflect new developments, to include guidance on further pre-authorisation procedures and to reflect the implementation of new European legislation. New or revised questions are marked with 'New' or 'Rev' together with the date of the update.

These questions and answers have been produced for guidance only and should be read in conjunction with the rules governing medicinal products in the European Union, volume 2, notice to applicants.

MAHs 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.

Similar-biological-medicine applications: Topics

The questions and answers on similar-biological-medicine applications address these topics:

Questions 1-10

 

Questions 11-20

Questions 21-30

 

Questions 31-44

 

If your question is not answered here please contact the Agency in advance of your planned submission.

Presubmission meetings

The Agency emphasises the importance of presubmission meetings, around six months prior to the anticipated date of submission of the application.

These are a vital opportunity for applicants to obtain procedural, regulatory and legal advice from the Agency.

These questions and answers and successful presubmission meetings should enable applicants to submit applications that conform with legal and regulatory requirements and can be validated speedily.

Presubmission meetings also enable applicants to establish contact with the Agency staff who will be involved with the application.

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PDF version of the questions and answers

Related information

Contact point:

Product and Application Business Support
E-mail: pa-bus@ema.europa.eu