Biologics: New study questions the need for 12 years of market exclusivity for biologics

24-06-2019

Biologics: New study questions the need for 12 years of market exclusivity for biologics

(Source: RAPS 2019-06-25)

The lengthy preclinical and clinical development necessary to bring a biologic to market has often been cited as one of the central reasons why biologics deserve 12 years of market exclusivity, or about five years more exclusivity than their small molecule counterparts.

But a new study published Tuesday in Nature Biotechnology shows that the development time of a new biologic is generally about the same as the development time of a small molecule drug.

The authors from the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School, note that “although biologics are often thought to be more time-consuming to develop than small-molecule drugs, development times for biologics are similar to, or possibly somewhat shorter than, for small-molecule drugs.”

The study found that of the 275 new drugs approved by the US Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) between 2007 and 2016 (77% were small-molecule drugs and 23% were biologics), median total development times—from first patent filing to FDA approval—were about 12 years for both types of products.

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