Biosimilars play a crucial role, created to expand access for patients unable to obtain certain biological medicines, as they replicate their biologic counterparts. Meanwhile, biologics, derived from living organisms and cells, are primarily used in the treatment of severe life-threatening diseases. A Biosimilar is defined as a biologic that has no clinical variances in terms of safety, purity, and potency (safety and effectiveness) compared to an existing 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 undergo evaluation for approval based on evidence presented by the manufacturer. FDA’s review involves thorough structural and functional comparisons of the Biosimilar with the reference product. Given the inherent variability in biologics manufacturing, FDA review also includes an evaluation of the manufacturer’s approach to managing the variation between different batches.
The Purple Book Database contains information on all FDA-licensed (approved) biological products overseen by the Center for Drug Evaluation and Research (CDER), including licensed biosimilar and interchangeable products alongside their reference products. It also includes data on all FDA-licensed allergenic, hematologic, vaccine, and cellular/ gene therapy products regulated by the Center for Biologics Evaluation and Research (CBER).