Biologics are created using living organisms and cells and typically are used to treat severe or life-threatening diseases. Biosimilars, on the other hand, were created to increase access for patients who couldn’t obtain a biological medicine, as they mimic their biologic counterpart. A Biosimilar is considered a biologic that has no clinical variances in terms of safety, purity, and potency (safety and effectiveness) from an existing and approved biologic, known as a reference product.

A reference product is a biologic that has been approved in a stand-alone application to demonstrate the product’s safety and effectiveness for each of the indications being sought by the manufacturer.

Biosimilars are evaluated for approval based on the evidence presented by the manufacturer. FDA’s reviewal of Biosimilars involve extensive structural and functional comparisons of the Biosimilar to the reference product. Biologics inherently exhibit a degree of variations through the manufacturing process. Therefore, an FDA review includes an evaluation of the manufacturer’s approach to managing the extent of variation between different batches.

More information on data requirements for the application can be found at

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