The European Medicines Agency
("EMEA") has updated its 2005 guideline on principles for
establishing biosimilarity between an innovator product and a
biosimilar ("Guideline on similar biological medicinal
products"; CHMP/437/04 Rev 1). The purpose of the document is
to provide regulatory guidance to biosimilar manufacturers that are
going to be referencing innovator product data as part of their
submission for regulatory approval. Similarity to the reference
product needs to be established for quality characteristics,
biological activity, safety and efficacy as part of a comprehensive
regulatory comparability evaluation. The release of the finalized
guideline follows circulation of a draft updated guideline in 2013
for industry comments (CHMP/437/04 Rev. 1). The new guideline is in
effect on April 30, 2015.
The latest revisions appear
intended to provide more regulatory certainty on standards, and to
make it easier, in some cases, to use non-European reference
products. The guideline explains how biosimilarity is judged with
respect to the key issues of safety, efficacy, quality and
biological activity. In general, comparability studies are needed
to generate evidence substantiating the similar nature, in terms of
quality, safety and efficacy, of the similar biological medicinal
product and the chosen reference drug already authorised in Europe.
In some cases the reference product may be one that is approved
elsewhere, such as the US, not Europe, if justifiable to
regulators. For example, bridging studies may be sufficient to
permit use of a non-European reference product. This is
significant, since it may permit biosimilar manufacturers to avoid
redoing clinical trials in Europe, making it simpler to approve a
This Guideline is to be read in
conjunction with more specific guidelines that may be applicable on
issues such as quality issues with biotechnology derived proteins
(EMA/CHMP/BWP/247713/2012), and clinical/non-clinical issues
(EMEA/CHMP/BMWP/42832/2005 Rev). There are also guidelines specific
to particular protein categories as monoclonal antibodies, and
specific proteins, such as filgrastim. Where there is a gap
in regulatory guidance, biosimilar companies 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.
The EMEA updated guidance also has
significance for biosimilar approvals in other countries. Since
Europe is a leader in developing biosimilar guidance, regulators
such as Health Canada often take European guidance documents into
This article was originally
published on AIPLA's Biotech Buzz, November 2014
The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.
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