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The introduction of two rival bills has intensified the long-simmering debate on biosimilars regulation in the US
BioPharm, 07/13/09

March 2009 was an active month for the proposal of legislation that would create a pathway for the US Food and Drug Administration to approve generic biologic drugs, or biosimilars. Two competing bills were introduced into the US House of Representatives, and one into the US Senate, that would provide such a pathway. This biosimilars legislation has been introduced during a time when healthcare reform in the United States, particularly in the area of maximizing affordability of prescription drugs, is receiving increased attention as a primary initiative of the Obama administration.

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