FDA-Meeting About Follow-on Protein Products

GMP News No. 479

14 October 2004

FDA-Meeting about Follow-on Protein Products

On September 14-15, 2004 the FDA held a public workshop on ScientificConsiderations Related to Developing Follow-On Protein Products. Thepurpose of this meeting was that the agency solicit the scientific andtechnological perspectives of manufacturers, academia, and otherinterested persons to determine the state of the science as it relates toprotein characterization, production, and assessment of similarity.

The information gained during the workshop will have an impact on the agency'sactivities in developing a draft guidance on this topic during the comingyear.

FDA uses the term "follow-on protein product" for a proteinthat is intended to be a similar version or copy of an already approved orlicensed protein pharmaceutical product. Such proteins might be producedthrough biotechnology or derived from natural sources.

This is a different definition compared to "second-generationprotein products" which are products that are similar to an alreadyapproved or licensed product but which have been deliberately modified tochange one or more of the product's characteristics (e.g., to provide morefavourable pharmacokinetic parameters or to decrease immunogenicity).

Although, this public workshop was not intended to address legal orregulatory issues, the presented information will influence FDA's opinionabout regulatory issues concerning protein products.

Therefore, the workshop results are of high interest for all who areworking in the field of protein characterization, production, andregulatory affairs.

Most of the workshop presentations can be downloaded here

Dr Ulrich Herber

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