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Focus on Regulation

EMA permits the use of a comparator product authorised outside the EEA in clinical studies for biosimilars

The European Medicines Agency’s (“EMA”) revised overarching guideline on biosimilars (“Guideline”), which was published on 23 October 2014, will come into force on 30 April 2015.

The purpose of this Guideline is to describe the concept of biosimilars and to outline the general principles to be applied when generating evidence substantiating the similar nature, in terms of quality, safety and efficacy, of the biosimilar and the reference medicinal product.

The revised Guideline introduces the possibility of comparing a biosimilar in certain clinical studies and in vivo non-clinical studies with a comparator product that is not authorised in the European Economic Area (“EEA”). According to the Guideline, this comparator must be authorised by a regulatory authority with similar scientific and regulatory standards as that of the EMA. The applicant for marketing authorisation will be responsible for establishing that the comparator is a representative of the reference medicinal product authorised in the EEA.

The Applicant must provide adequate data to scientifically justify the relevance of the comparative data and establish an acceptable link between the comparator and the reference medicinal product. To establish this link, the applicant must submit data from analytical studies that compare all three products (the proposed biosimilar, the reference medicinal product and the non EEA-authorised comparator). This can also include data from clinical PK and/or PD bridging studies for all three products.

Determination of the adequacy of such scientific justification and the link between the non-EEA authorised comparator with the reference medicinal product will be made by the relevant competent authorities on a case by case basis.

In addition, the revised Guideline also clarifies a number of key principles in light of the experience gained since the initial Guideline released in September 2005. This includes:

  • the terminology for biosimilars;
  • the principles of biosimilarity, including safety and efficacy of the biosimilar and the reference medicinal product; and
  • the requirements regarding the posology, route of administration and formulation of biosimilars.