So biomedical research is advancing really rapidly.
And a key part of that advancement are analytic capabilities.
To give you perspective about how these have changed, if you compare the current really
high definition TVs to the older VGA computer monitors, they’re about 100 times greater
resolution.
And yet analytical tools—for example, mass spectrometry is a very important analytical
tool—have increased the resolution by thousands of times.
There are all kinds of tools to measure how the proteins fold in three-dimensional space,
some direct and indirect.
These are very, very powerful and sensitive tools to measure the products that we are
evaluating.
And so, in evaluating this large amount of data, it’s how the companies develop these
products and regulators listen to this information.
And that involves assessing what parts of it are most important, in terms of how they
will perform clinically, and usually there are tools like risk assessment in order to
really prioritize how you look at it.
So you look at all the information—that you really focus on the parts that really
matter the most to the patient.
Part of a biosimilar application will actually be a direct comparison between the biosimilar
proposed product and the reference product.
And that will involve a very careful characterization of the reference product, sort of ranking
the importance of difference attributes of that molecule and then comparing them using
these sophisticated tools.
And as an additional check on this, not only are these tools measuring structure; they’re
also measuring the biological activity of the molecules—what they really need to do
in the body in order to have their desired effect.
And so these analytical tools support the similarity of the molecules but also can help
answer questions.
If there is a small difference, they can help determine whether or not that difference really
will matter to the patient and will impact the assessment of the similarity.
So the law that allows the biosimilar development talks about three types of data.
It talks about analytical data.
It talks about animal data and it talks about one or more clinical studies.
And so those are generally needed, although there is the ability to waive one of those
should they not be needed.
And so this more importantly—that the type of data that’s brought in each of those
categories may differ.
So for instance, if a manufacturer has a really powerful analytical comparison, that information
is viewed at in the context of the whole assessment, and that may change what’s expected and
some of the other categories of data— so a concept of totality of evidence that it’s
not.
There’s a fixed amount in each bucket that’s needed.
But it’s that overall information about whether this molecule is truly biosimilar
to the reference product.
The analytical similarly is the foundation of establishing biosimilarity because by showing
that the molecule being development has highly similar structure, has very similar function,
may bind the same receptor in the same way as the reference product, will have the same
biological activity in terms of activating living cells in a model of that all those
things together really give you the starting point that the biosimilar candidate will act
the same way as the reference product in patients.
And the remainder of the development involves studies that confirm that.
But that analytical piece really sets the stage for biosimilarity.
There is a requirement to be analytically highly similar.
And that’s necessary for approval as a biosimilar.
But there may be ways of doing that that provide greater confidence.
And that may affect how much information you need in the other buckets.
And there also may be other differences in how companies make their case.
And we certainly want to be flexible as long as there’s evidence that this product is
biosimilar, meets the requirements—there may be different ways of doing that.
So I think one of the things that’s exciting is, as these technologies get better and better,
I think that will really facilitate the development of these products in the most efficient ways
possible.
And that will really help access to medicines by patients.
So we really have to look to not only what can happen now, but in fact, there’s a brighter
future for this type of product.