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  • Orange Book Blog is published for informational purposes only; it contains no legal advice whatsoever. Publication of Orange Book Blog does not create an attorney-client relationship. Orange Book Blog is Aaron Barkoff's personal website and it is intended primarily for other attorneys. Orange Book Blog is not edited by McDonnell Boehnen Hulbert & Berghoff LLP ("MBHB") or its clients. Therefore, no part of Orange Book Blog--whether information, commentary, or other--may be attributed to MBHB or its clients. Readers should be aware that MBHB represents many companies in the pharmaceutical and biotechnology industries, and therefore Orange Book Blog may occasionally report on news that relates to MBHB clients. Orange Book Blog will always strive to be unbiased in its reporting. All information on Orange Book Blog should be double-checked for its accuracy and current applicability. -- © Aaron F. Barkoff 2006-08

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September 20, 2006

Rep. Waxman Announces Plan to Introduce Biogenerics Legislation; Governors Petition FDA on Biogenerics

Representative Henry Waxman (D-CA) announced plans to introduce legislation that would establish an FDA approval process for generic biologics.  He announced his plans in a speech to the Generic Pharmaceutical Association (GPhA) yesterday.

Rep. Waxman stated, "I intend to introduce legislation that will establish a clear pathway for generic biologics very shortly."  Moreover, the pathway should include evaluation of biological products on a "case-by-case approach" due to the "uniqueness of biological products."

Last month, the governors of four states filed a citizen petition asking the FDA to release guidance for industry that would explain the requirements for applications seeking approval to market generic insulin and human growth hormone.

RELATED READING:

NOTE:  Thanks to a helpful reader for providing a copy of Rep. Waxman's remarks to GPhA.

Posted by Aaron Barkoff in Biosimilars |

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