FDA Review and Approval Process for Biosimilar Medications

Biosimilars are FDA-approved biological products that are safe and effective options for existing biologics, called reference products. For both reference products and biosimilars, the FDA requires the manufacturing process to be carefully controlled and monitored to maintain safety and effectiveness between batches. Because biologics are usually made from living sources, there are inherent variations in any batch or dose. As part of the approval process, the FDA assesses a

manufacturers plan to control for variations between batches of the biological product. A biosimilar manufacturer must also demonstrate that a proposed biosimilar is highly similar to and has no clinically meaningful differences from the reference product. Extensive comparative analytical data serve as the foundation of the FDAs approval process. The analytical data show that the biosimilar and the reference product are highly similar, including in the pattern and consistency

of variations. These data also help determine what other studies may be needed for approval. Manufacturers generate these data, using powerful and sensitive tools such as mass spectrometry and ligand-binding assays to compare the products structure and function. Data from animal, clinical pharmacology, and comparative clinical studies may also support the demonstration of biosimilarity. Together, this information helps link the safety and effectiveness of the proposed biosimilar to the

FDAs findings of safety and effectiveness for the reference product. These robust tools and detailed analytical comparisons are crucial to reducing the time and cost of product development and approving safe and effective biosimilars. For more information, explore the FDAs biosimilar resources for health care professionals at fda.gov/biosimilars.