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Lindsey Robinson

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Lindsey Robinson
B.A. (Hons.), LLM
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Europe Developing More Specific Criteria for Biosimilar Drug Safety Data

May 5, 2014

Author: Noel Courage

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 approach immunogenicity. 

The EMEA intends to further address the following topics:

More specific guidance for the presentation of immunogenicity data;
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 efficacy;
Comparative immunogenicity studies; and
Post-licensing immunological studies.

Information on this website is for information only. It is not, and should not be taken as, legal advice. You should not rely on, or take or not take any action, based upon this information. Professional legal advice should be promptly obtained. Bereskin & Parr LLP professionals will be pleased to advise you.

 

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