Biosimilars
A biosimilar mAb must be as similar to the parent
therapeutic as possible. Unlike the previous examples, the
goal is not to increase the T
m
or T
on
, and in fact, the aim is
to keep the thermal unfolding profile as similar as possible
to the original. This is a critical proof point for regulatory
agencies, which require a biosimilar has no clinically
meaningful differences from its reference biologic.
In order to get the best accuracy for your similarity
values, it's critical to obtain high-resolution data from
your thermal stability experiments. This ensures you are
progressing with the biosimilar most like its originator,
which satisfies the demands of regulatory agencies.
