What are biobetters? You might ask. Let us recall what other new
coined terms we have and then explain what they are.
Biologics are biopharmaceutical products, which we have been using for in
rheumatology about two decades now. Biosimilars
are somehow generic biologics that
may be approved after patent expiry of the original drug. Biosimilars are not
completely identical to the original products.
Biobetters are also biosimilars, but they
are improved compared to the originator drug. The active part the biobetter may
use another protein than the originator drug or use glyco-engineering like pegylation
to create a drug that addresses the same target as the originator drug, but its
effect on the target may last longer and the risk of immunogenicity may be
reduced. A biobetter will be considered a new drug and therefore enjoy market
protection. But the biobetter will have
to show new efficacy and safety data, which means the companies will have to
invest in lengthy phase 3 studies, which the biosimilars don’t have to do.
Will we hear more about biobetters? I bet yes. Why haven’t we heard about
an adalimumab biobetter as Humira’s patent expires? The biobetter would have to
compete with four or five biosimilars, which require fewer costs to develop. The
real advantage of a biobetter lies in the fact, that it could be launched in
the market before the patent on the originator drug expires. If this new
concept will have an impact in rheumatology will yet have to be shown.
What are biobetters? Biosimilars, which improve on the originator drugs.
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