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European Medicines Agency to revise biosimilars guideline

Regulator's advisors suggest clarifying the principles of biosimilarity

The European Medicines Agency (EMA) plans to update its guideline on biosimilars in a process that could see changes to the way they are authorised

The existing guideline, CHMP/437/04, came into effect in 2005 – before any biosimilars were marketed in the EU. Its purpose was to introduce the concept of biosimilars, outline the basic principles to be applied and serve as a user guide for applicants.

But in a concept paper released for consultation until February 2012, the agency's scientific committee, the CHMP says many terms are being used for “biosimilar” or “similar biological medicinal product”, and that “biosimilar” is often used inappropriately.

As such, the committee says it may be prudent to examine whether a definition for biosimilar is necessary, beyond what is in the EU legislation (Directive 2001/83/EC) and the relevant CHMP guidance.

The CHMP recommends a range of issues that should be considered when revising the guideline. For example, it says the principles of biosimilarity may have to be clarified so that readers can easily understand the aim of a biosimilars development programme, i.e. to establish similarity to the reference product, rather than clinical benefit.

The committee also calls for a discussion on whether it is feasible to follow the legal basis for generics for some biological products. Moreover, an assessment may be necessary to clarify whether there are exceptional circumstances under which a biosimilar could be authorised based on a bioequivalence study only, combined with an extensive quality comparability exercise.

In addition, there are specific parts of the existing guideline that need further discussion and refinement, according to the CHMP. These include efficacy and safety aspects, language about pharmaceutical form, strength and route of administration, and references to numerous guidelines, some of which are outdated.

Since the existing guideline's introduction the CHMP has had considerable experience with scientific advice procedures and marketing authorisation applications for biosimilars and hopes the document will reflect its greater understanding of these products, both conceptually and from a data perspective.

The CHMP expects to release a draft of the revised guideline for consultation in the first half of 2012.

1st December 2011

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