FDA Review and Approval Process for Biosimilar Medications

A biosimilar is a biologic that is highly similar to and has no clinically meaningful differences in terms of safety, purity, and potency (safety and effectiveness) from an existing FDA-approved biologic, called a reference product. All FDA-approved biologics undergo a rigorous evaluation so that health care providers and patients can be confident of the safety, effectiveness, and quality of these products.

FDA approves biosimilars through an abbreviated pathway. The goal of a biosimilar development program is to demonstrate biosimilarity between the proposed biosimilar and its reference product, not to independently establish the safety and effectiveness of the proposed biosimilar. This generally means that biosimilar manufacturers do not need to conduct as many expensive and lengthy clinical trials. This video explains the approval process for biosimilars, including the data requirements for approval

For more information, visit https://www.fda.gov/biosimilars