What are biosimilars?

Biosimilars are defined as molecules that are highly similar to an already FDA-approved biological medication, known as the reference product. They are designed to have no clinically meaningful differences in safety, purity, and potency when compared to the reference product. This similarity to the original product allows for the potential to provide similar therapeutic effects for patients, while often being available at a lower cost which can improve access to necessary treatments.

Unlike options suggesting that biosimilars are exactly identical to the reference product or represent entirely new compounds, the essence of biosimilars lies in their close resemblance rather than perfection in molecular structure. This recognition allows healthcare professionals to utilize biosimilars effectively while understanding their role in treatment protocols without assuming they are completely interchangeable in all scenarios, particularly if there are different patient responses.

Thus, the characterization of biosimilars as molecules similar to originally FDA-approved medications captures their essence as derivatives that maintain efficacy and safety while benefiting the healthcare system through cost reduction.