ABSTRACT
This chapter deals with developing an understanding about biosimilarity as expressed by the Food and Drug Administration (FDA) in its publications, guidances, and regulatory documents that the FDA shared with the public. The product is highly similar to the reference product notwithstanding minor differences in clinically inactive components, and there are no clinically meaningful differences between the biological product and the reference product in terms of safety, purity, and potency of the product. The sponsor should provide adequate data or information to scientifically justify the relevance of these comparative data to an assessment of biosimilarity and to establish an acceptable bridge to the US-licensed reference product. The goal of a biosimilar development program is thus to demonstrate that the proposed product is biosimilar to the reference product. The potency of the biosimilar products is compared with that of the originator reference product as a definite measure of biosimilarity based on two considerations: protein content and functional response of the protein.
