In 2010, the Biologics Price Competition and Innovation Act was signed into law and created an abbreviated approval process for biosimilars in the US. The FDA defines a biosimilar as a biological product that is "highly similar to the US licensed reference biological product notwithstanding minor differences in clinically inactive components; and that there are no clinically meaningful differences between the biologic product and the reference product in terms of the safety, purity, and potency of the product." Two biosimilars are now approved in the US, with more approvals anticipated in the near future. Expanded patient access to biologic therapies and reduced health care costs are projected benefits associated with the introduction of biosimilars into the US market.

FDA. Accessed Feb 2015.
Weiss M, Bielsky MC, De Smet K, et al. Blood. 2012;120:5111-5117.
Lucio S, Stevenson, J, Hoffman J. Am J Health Syst Pharm. 2013;70:2004-2017.


11-Minute Tutorial on Biosimilars

Listen to Dr. Edward Li describe the similarities and differences between biosimilars and reference biologics, and review current FDA regulation guidance



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