Tuesday, December 27, 2016

Biobetters, Biologics, Biosimilars etc.

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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