Immunogenicity of biosimilar medicines has been a key concern
for regulators. They want to minimize risk that a patient receiving
a biosimilar medicine will be at risk of having an adverse immune
response to the biosimilar. It has also been a key potential
patient safety issue in the often polarized discussion between
innovator and biosimilar manufacturers.
The European Medicines Agency intends to revise a Guideline
that provides recommendations for the immunogenicity
assessment of a biosimilar protein drug. This Guideline is of
interest to biosimilar manufacturers that intend to submit an
application for marketing authorization. As an initial step, the
EMEA released a draft concept paper in March 2014, which has a
deadline for comments on June 30, 2014. The
concept paper is a precursor to the release of draft revised
guideline that would eventually update the current Guideline that
has been in effect since 2008. A primary goal of the eventual
revisions is to define more specifically the requirements of
immunogenicity assays. The concept paper states that EMEA feels
that many past marketing authorizations lacked a clear strategy to
The EMEA intends to further address the following topics:
More specific guidance for the presentation of immunogenicity
Requirements of data on antibody assays;
Role of in vitro and in vivo non-clinical studies;
Risk-based approach to immunogenicity;
Clinical data to study the correlations of the induced
antibodies to allergic and anaphylactic/anaphylactoid reactions,
delayed immunological reactions, pharmacokinetics, lack of
Comparative immunogenicity studies; and
Post-licensing immunological studies.
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