Figure 1.

Biologics manufacturing processes. Manufacturing biologics includes a number of steps that may vary among manufacturers. This variance may lead to differences between a biosimilar and its reference product that cannot be fully characterized with currently available analytic techniques. Smallmolecule drugs, by contrast, are synthesized using reproducible chemical reactions to make identical copies (generics) that can be fully characterized with available analytic methods. Used with permission from Mellstedt, Niederwieser, & Ludwig (2008).