Unlike small-molecule drugs and corresponding generics that are manufactured via chemical synthesis, biologics undergo essential post- translational modifications when manufactured in living cells.
Large molecule drugs
Bioequivalent, but not interchangeable
Lower capital expenditure
In contrast to generic small-molecule drugs, interchangeable biosimilar drug products do not currently exist, predominantly because of the inherent complexity of biological drug products and the necessity for high quality standards for bioequivalence, potency and purity.
Time to develop with existing technologies