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Towards Understanding the “Generic" Debate About Biologics

01 October 2004

Journal of Biolaw & Business, Vol. 7, No. 4
Much has been written debating different aspects of the same controversial topic variably known as "generic biologics," "follow-on biologics," "follow-on biotechnology products," "follow-on therapeutic proteins" and "generic biopharmaceuticals." Many considerations pertaining to various legal, scientific, economic, policy and social issues involving the legislative, executive, and judicial branches of the government are relevant though the debate is especially complicated because of definitional and interpretative problems. Further, the controversies themselves are often confused and confusing due to the use of different terminology. While this article cannot clarify or simplify in the limited space available all of the complexities, it is designed to further understanding of the multiple issues related to the "generic" debate about biologics.
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