In biosimilar development, the analytical data is the foundational component to demonstrating the level of similarity a biosimilar has to a reference product.1
Product quality is critical to the efficacy, safety, and
immunogenicity of all medicines and is assessed at the earliest stage of
development and continually through the medicine’s commercial production.
However, it is not enough to just test the product quality—the methods used for these tests must be
sufficiently sensitive and have a high enough resolution to ensure that
differences can be detected if they exist.
Different companies will take different approaches to analytical
testing. The detail of information developed about the product is impacted both
by how the test is performed and the actual tests used.
Analytical techniques vary in their quality
just as a photograph can vary in quality. Two of the measures that scientists
often use to describe the quality of a method are resolution and sensitivity.
Just as low resolution in a photograph can hide important details, low
resolution in an analytical method can mask differences in products.
On this page, there are two otherwise
identical photographs with different resolutions and two sets of hypothetical analogs representing two attributes in the same proportion but with different
In these examples, information about the
succulent plant is less apparent in the photograph with low resolution, just as
information about the smaller peak, which represents a product attribute, is
lost in the example with low resolution. This would be
particularly important when the smaller peak represents an attribute that
impacts how the drug works. Similarly, sensitivity is like contrast: the more
sensitive a method is, the better it is capable of detecting a small