Quality of Biosimilars

Biosimilars offer efficacy, safety, and purity comparable to their reference products.
Overview
Benefits
Assessment
FAQ

Biosimilars are rigorously reviewed to ensure that they meet safety and efficacy requirements established by the US Food and Drug Administration (FDA).

Both nonclinical and clinical evaluations must be completed to determine biosimilarity to a reference drug

Biosimilars follow an established development path.


Invention is not the only innovation.

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  1. FDA's Overview of the Regulatory Guidance for the Development and Approval of Biosimilar Products in the U.S. https://www.fda.gov/downloads/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalapplications/therapeuticbiologicapplications/biosimilars/ucm428732.pdf