Follow-on biologics/biosimilars are defined as which type of drugs?

• A. Small molecule generics
• B. Over-the-counter analgesics
• C. Drugs produced in living cells
• D. Herbal supplements

Answer: (C)

Biosimilars are drugs produced in living cells. Biologics are large, complex molecules—proteins or protein-based therapies—made using biotechnology in cell culture, rather than being chemically synthesized like small-molecule drugs. Because of their complexity and the way they’re produced, exact copies aren’t feasible, so biosimilars are “highly similar” to the reference product with no clinically meaningful differences in safety, purity, or potency, proven through a stepwise comparability program.

This is different from small-molecule generics, which are chemically identical copies of simple drugs. It’s also not about over-the-counter analgesics or herbal supplements, which fall into different, non-biologic categories.