Need for a risk-based control strategy for managing glycosylation profile for biosimilar products.

We propose that manufacturers should focus on those glycoforms that are present in larger amounts and are known to be critical with respect to the biotherapeutic's safety and efficacy. Such risk-based evaluation of glycoforms and their control would offer an optimal route to biosimilar manufacturers for a cost-effective approach toward product development without compromising on the safety and efficacy characteristics of the therapeutic. For mAbs lacking Fc effector function, devising stringent glycosylation control strategies can be bypassed, thereby simplifying process and product development.