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Biosimilars: Here and Now.

Congress passed the Biologics Price Competition and Innovation Act (BPCI Act) as part of the Affordable Care Act on March 23, 2010. The BPCI Act authorized an approval pathway for biosimilar and interchangeable products. It defines biosimilarity to mean "that the biological product is highly similar to the reference product notwithstanding minor differences in clinically inactive components" and that "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 biosimilar pathway has the potential to facilitate access to biologic products through increased competition, in the same manner as biosimilars have done for almost 10 years in Europe. The goal of a biosimilar program is not to independently establish safety and effectiveness for each condition of use. Rather, the goal is to demonstrate biosimilarity through an extensive analytical characterization and a targeted clinical program designed to assess for clinically meaningful differences, if they exist. The regulatory approaches in both the United States and Europe involve a totality-of-the-evidence approach to demonstrate biosimilarity. Importantly, the biosimilar pathway allows for extrapolation of data across indications so that a sponsor, with adequate scientific justification, need not conduct clinical studies in each intended condition of use. Without extrapolation, development may not be feasible for many products, and patients and resources could be diverted from clinical studies of newer agents for cancer.