Publication Date
2010
Abstract
The creation of an approval pathway for biosimilar biologicalproducts holds tremendous promise for increased competition in the biopharmaceutical market and financial savings to the health care system. Yet, safely achieving these promised benefits depends heavily on the Food and Drug Administration's ability to evaluate and compare these complicated molecules to previously approved products. Because biosimilars are different than generic drugs, the FDA's current practice of considering only its prior finding of safety and efficacy of a reference product is ill-suited for approval of biosimilars. Unfortunately, the new pathway included in recently enacted health care reform legislation ignores this distinction and the need for FDA discretion to look at the data supporting approval of reference products when evaluating a biosimilar application. This Note demonstrates that allowing the FDA to make active comparisons between a biosimilar application and the applications of previously licensed products would improve product safety and help facilitate licensure of biosimilars. Furthermore, this Note evaluates existing case law and regulations to show that this internal Agency use of arguably trade secret data would not violate the Takings Clause.
Recommended Citation
Little,, John A. Jr.
(2010)
"Taking from Trailblazers: Learning from Those Who Have Gone Before when Approving Biosimilars,"
Georgia Law Review: Vol. 44:
No.
4, Article 8.
Available at:
https://digitalcommons.law.uga.edu/glr/vol44/iss4/8