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EMA releases a draft revision to the Biosimilars Guideline for public consultation

Alexander Roussanov

22 May 2013
The European Medicines Agency ("EMA") initiated a public consultation on a proposed revision of its Guideline on "Similar Biological Medicinal Products" (the "Biosimilars Guideline"), available at the EMA website . The 2 April 2013 proposed revision would ultimately result in a new guideline replacing the current Biosimilars Guideline adopted in October 2005.

The draft revision of the Biosimilars Guideline

The draft revision of the Biosimilars Guideline reflects the main principles set out in the current version of the Guideline. It describes the concept of biosimilar and provides the general principles to be applied in the assessment of applications for marketing authorisation of biosimilars. This includes the choice of a reference biological medicinal product and the principles for establishing biosimilarity between the reference product and the biosimilar.

New element: clarification that the EMA assessment does not cover the interchangeability between the biosimilar and the reference medicinal product

One new element introduced in the draft revision of the Biosimilars Guideline is a reference to interchangeability between the biosimilar and its reference medicinal product. The draft revision states that the assessment of an application for marketing authorisation for a biosimilar conducted by the EMA does not include recommendations on whether a biosimilar should be used interchangeably with its reference medicinal product. This statement is not surprising as the EMA has no power to make such a determination as this is governed by the national laws of the EU Member States.

New element: use of comparator medicinal products that are not authorised in the EEA in certain studies

The requirement that the reference product for the biosimilar must be authorised in the European Economic Area ("EEA") set out in the current version of the Biosimilar Guidelines is repeated in the draft revision. However, a new element is also introduced.

The draft revision provides that applicants for marketing authorisation for biosimilars may conduct "certain clinical studies and in vivo non-clinical studies" with a comparator medicinal product that is not authorised in the EEA.

The introduction of the possibility for applicants to use data generated in studies with comparator medicinal products that are not authorised in the EEA is intended to facilitate the global development of biosimilars and to avoid unnecessary repetition of clinical trials. This possibility is subject to a number of conditions:

  • the comparator medicinal product that is not authorised in the EEA should be a version of the reference medicinal product authorised in the EEA. The term "version" is not defined in the draft revision of the Biosimilars Guideline; and
  • the comparator medicinal product should be authorised by a regulatory authority on the basis of scientific and regulatory standards that are similar to the standards used by the EMA for the assessment of applications for marketing authorisation of biological medicinal products. The draft revision of the Biosimilars Guideline does not, however, define what the term "scientific and regulatory standards" means; and
  • the applicant must establish that the comparator medicinal product is representative of the reference medicinal product. The draft revision of the Biosimilars Guideline does not include a definition of the term "representative" or a discussion concerning the criteria for the demonstration that the comparator medicinal product is representative of the reference medicinal product; and
  • the applicant should provide data that scientifically justifies the relevance of the data generated in the studies conducted with the comparator medicinal product;
  • the applicant should provide bridging data linking the comparator medicinal product, the reference medicinal product and the biosimilar.

The draft revision of the Biosimilars Guideline also provides that the acceptability of the data generated in studies conducted with a comparator medicinal product that is not authorised in the EEA would be assessed by the EMA on case-by-case basis as part of the assessment of the application for marketing authorisation for the biosimilar.

Next steps:

The public consultation concerning the proposed revision of the Biosimilars Guideline is open until 31 October 2013. After the end of the public consultation the EMA will discuss the feedback and will prepare the final draft of the revised Biosimilars Guideline.

Once adopted, this final draft will replace the current Biosimilars Guideline, which was adopted in October 2005.

Alexander Roussanov

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