The Committee for Medicinal Products for Human Use (CHMP) issues specific guidelines concerning the
scientific data to be provided to substantiate the claim of similarity used as the basis for a Marketing
Authorisation Application (MAA) for any biological medicinal product (as defined in Section 3.2.1.1, Part
I, Annex I to Directive 2001/83/EC, as amended).
The scope of the guideline is to fulfil the requirement of section 4, Part II, Annex I to Directive
2001/83/EC, as amended, which states that ‘the general principles to be applied [for similar biological
medicinal products] are addressed in a guideline taking into account the characteristics of the
concerned biological medicinal product published by the Agency’.
Therefore, the purpose of this guideline is to describe the concept of similar biological medicinal
products (hereby designated as “biosimilars”) and to outline the general principles to be applied.
Applying these principles will be indicated below as the “biosimilar approach”.
The CHMP guidelines addressing the planning and conduct of biosimilar comparability studies should
always be read in conjunction with relevant scientific guidelines and legislative provisions in force in
the European Union.
Companies developing biosimilars are invited to contact Regulatory Authorities in the EEA to obtain
further advice on their development, whenever there is a need for more detailed information than
provided in the guidelines already available.
Evaluation of biosimilar medicines for authorisation purposes by the EMA does not include
recommendations on whether a biosimilar should be used interchangeably with its reference medicine.
Substitution policies are within the remit of the EU member states.
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