Do you find that glycosylation is an issue mainly in biosimilars? It seems everything I read on this talks about trying to match the profile of an innovator product?

Answer

Conceptually this questions addresses the issue of targeting a particular glycan profile.  It is true that there is a target profile for both innovator biologics and biosimilars.  For the biosimilars, the target is clear – it is the glycan profile of the innovator. For the innovator, in the case of antibodies, there may be a desire to target a profile that increases antibody-dependent cell-mediated cytotoxicity (ADCC) over complement-dependent cytotoxicity (CDC) or increases half-life of the antibody in circulation, or a certain profile may have been specifically targeted in R&D.  In some cases, the optimal candidate was chosen empirically during biological testing and then becomes the target profile.  In any scenario, glycan addition drives functionality, and this is true for both the innovator and the biosimilar.  In some cases, researchers have determined that the innovator glycan profile is not be the best and have developed therapeutics with improved glycan profiles.  These “improved” therapeutics are part of a relatively new class called bio-betters.