A biosimilar product is a biologic product that is approved based on the demonstration that it is highly similar to an FDA‐approved biologic product, known as a reference product, and has no clinically meaningful differences in terms of safety and effectiveness from the reference product. Only minor differences in clinically inactive components are allowable in biosimilar products.
While identical generic versions of small molecules can typically be chemically synthesized, it is not possible to create identical versions of reference biologic medicines, due to their complexity. Therefore, the processes used to develop generic medicines cannot be applied to the development of biosimilar medicines.
Biosimilars (and reference biologics) are created in living cells and require significant expertise and state-of-the-art technology in development and manufacturing.
SMALL-MOLECULE DRUG
SMALL BIOLOGIC
LARGE BIOLOGIC
Small-molecule drugs are smaller and less complex than biologics and are chemically synthesized
Conversely, biologics are larger and more complex and are created from living cells
