Biosimilars Pathway: A Far Cry From Hatch-Waxman

Law360, New York (March 30, 2010, 2:24 PM EDT) -- On March 23, 2010, President Obama signed into law Pub. Law. No. 111-148, the APPROVAL PATHWAY FOR BIOSIMILAR BIOLOGICAL PRODUCTS (i.e., Biosimilars Pathway), a component of the Patient Protection and Affordable Care Act. This legislation creates, for the first time, a pathway for the production, use and sale of follow-on biologic therapeutics in the United States.

The U.S. is now among many countries in the world having a pathway for biosimilar products, including those in the EU that, in 2004, adopted biosimilars legislation and subsequently approved...
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