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Significant differences exist between biologic medicines including innovator biologics, biosimilars, and biobetters compared with chemically synthesized or isolated small molecule drugs (SMDs) and their generics. Biologics and biosimilars are in a different league to their chemical pre‐predecessors in terms of molecular complexity and natural variability.

Table 1.3 Pivotal differences between biologics and small molecule drugs.

Biologics	Small molecule drugs (SMDs)
Large/complex molecules or mixtures of these molecules	Well‐defined chemical structures
Product is the process: >1000 process steps	Manufactured by chemical synthesis: specific agents are used in an ordered/sequential manner
Living processes that are very sensitive to minor changes in manufacturing: may alter the product and its function (efficacy, safety)	Well‐defined chemical synthesis or isolation: subject to lower batch‐to‐batch variability
Product quality, purity, and function are ensured by “stable” or “consistent” manufacturing	Each individual component of the finished drug product is identified and quantified
Unwanted immune reactions are common	Unwanted immune reactions are rare

First and foremost, biologics are produced in living cells or organisms and are not chemically synthesized. Many of the other factors that hinder the full acceptance of biosimilars stem from these critical differences in the properties of biologics and SMDs. A summary of the pivotal differences between biologics and SMDs is provided in Table 1.3. Pharmacists and doctors need to keep these key differences in mind when having conversations about biosimilar medicines.