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Articles

Biosimilars vs. Generics - Major Differences in the Regulatory Model

March 13, 2012

Articles

Biosimilars vs. Generics - Major Differences in the Regulatory Model

March 13, 2012

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On February 9, 2012, the U.S. Food and Drug Administration (FDA) published its long-awaited biosimilar guidance documents as a follow-up to the Biologics Price Competition and Innovation Act of 2009 (Biosimilars Act) that was signed into law by President Obama on March 23, 2010. The legislation, which was inspired by the 1984 Hatch-Waxman Act establishing a generic pathway for small molecule drugs, provides a new biosimilar pathway for the approval of large molecule (biologic) drugs.

While there are important similarities in the two regulatory schemes, there are many more differences. Generic manufacturers who are familiar with Hatch-Waxman and are looking for expedited entry into the biosimilars market may be disappointed.

To learn more, please read Biosimilars vs. Generics – Major Differences in the Regulatory Model.

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