Cardozo International & Comparative Law Review
Abstract
The note examines the legal and regulatory landscape surrounding biologic drugs and biosimilars in the United States and Europe, focusing on patent protections, litigation trends, and the impact of biosimilar competition on drug pricing. It highlights the challenges posed by patent thickets and evergreening strategies employed by brand-name biologic manufacturers, which delay biosimilar market entry and maintain high drug prices. The analysis underscores the differences in regulatory frameworks and market dynamics between the U.S. and Europe, emphasizing the need for policy reforms to enhance competition and affordability in the biologic market.
Disciplines
Comparative and Foreign Law | Food and Drug Law | Intellectual Property Law | International Law | International Trade Law | Law | Science and Technology Law
Recommended Citation
Lauren Cutler,
Tackling the Thicket: A Comparative Analysis of Biologic Drugs and Biosimilars in the United States and Abroad,
7
Cardozo Int’l & Compar. L. Rev.
675
(2024).
Available at:
https://larc.cardozo.yu.edu/ciclr/vol7/iss2/8
Included in
Comparative and Foreign Law Commons, Food and Drug Law Commons, Intellectual Property Law Commons, International Law Commons, International Trade Law Commons, Science and Technology Law Commons