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« Mikkilineni v. Stoll (Fed. Cir. 2010) | Main | Patenting Information »

November 30, 2010


Can you advise where the EMA provided guidance (if they have) on the nature of the underlying STRUCTURAL identity required in addition to the testing? I didn't see anything that specified sequence homology, glycosylation similarity, or any other structural requirements. Is there any requirement for process similarity (cell type in which the MAbs are synthesized)?


It appears that the EMA would want biosimilar applicants to address those "factors" at the step 2 in vitro testing phase. There are no explicit structural guidelines presented, although cell line choice is mentioned in the context of potential process impurities.

Since each biosimilar mAb situation will present different obstacles, the way I read the guidelines is if a biosimilar applicant seeks to produce a mAb in a different cell line, that will have to be justified to the relevant authority, and additional testing would be required (in this case only) to verify that no harmful impurities are generated from use of the different cell line. But use of another cell line is theoretically permitted as the guidelines currently stand.

As long as the biological activity (and safety profile) of the biosimilar mAb is comparable to the reference product, the structural equivalance of the biosimilar mAb does not appear to be critical. Of course, substantial structural differences between the reference product and the biosimilar would likely alter the biological activity as well.

Thanks for the comment.


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