On September 14-15, 2004 the FDA held a public workshop on Scientific
Considerations Related to Developing Follow-On Protein Products. The
purpose of this meeting was that the agency solicit the scientific and
technological perspectives of manufacturers, academia, and other
interested persons to determine the state of the science as it relates to
protein characterization, production, and assessment of similarity.
The information gained during the workshop will have an impact on the agency's
activities in developing a draft guidance on this topic during the coming
year.
FDA uses the term "follow-on protein product" for a protein
that is intended to be a similar version or copy of an already approved or
licensed protein pharmaceutical product. Such proteins might be produced
through biotechnology or derived from natural sources.
This is a different definition compared to "second-generation
protein products" which are products that are similar to an already
approved or licensed product but which have been deliberately modified to
change one or more of the product's characteristics (e.g., to provide more
favourable pharmacokinetic parameters or to decrease immunogenicity).
Although, this public workshop was not intended to address legal or
regulatory issues, the presented information will influence FDA's opinion
about regulatory issues concerning protein products.
Therefore, the workshop results are of high interest for all who are
working in the field of protein characterization, production, and
regulatory affairs.
Most of the workshop presentations can be downloaded here.
