Generic Biologics

H.R. 6257: Access to Life-Saving Medicine Act

On September 29, 2006, Rep. Waxman, along with Senators Charles E. Schumer and Hillary Rodham Clinton introduced H.R. 6257, the "Access to Life-Saving Medicine Act, which will establish a process through which the FDA will be able to approve lower cost copies of biotech drugs, also known as biologics or biopharmaceuticals. For more information, including the text and summaries of the bill; background information on generic biologics, and letters of support from AARP, Consumers Union, the AFL-CIO and other civil society groups, see Representative Henry Waxman's Page on H.R. 6257.

Further Information on Generic Biologics

Biotechnology Industry Organization Page on Follow-On Biologics

April 10, 2007. Robert Pear for the New York Times. Congress Seeks Compromise on Generic Drugs.

April 10, 2007 Wall Street Journal Editorial. Dr. Waxman's Drug Lab.

September 29, 2006. Biotechnology Industry Organization. Imperative To Recognize Differences Between Biologics and Other Drugs.

August 15, 2006. Aaron Smith for CNN Money. Missing the $20 billion biogeneric boom - Biotech drugs could lose patents in coming years, creating a biogeneric opportunity ... but there are barriers.

January 18, 2006. Pharmaceutical Business Review. Biogenerics: the battle is only just beginning.

April 2005. Deborah Shelton in Pharma & Bio Ingredients. Moving Toward Biogenerics in the U.S.

May, 2004. IMS-Health. Biogenerics: A Difficult Birth?

June 2001. Timothy B. Coan and Ron Ellis. Report for USA Specialty Pharmaceuticals. Generic Biologics: The Next Frontier.

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