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2009 Biologics and Biosimilars Archive

July 15, 2009: The Senate's Health, Education, Labor, and Pension Committee, under the chairmanship of Senator Edward Kennedy, approved the HELP Health Reform Bill, which includes a provision that would provide a minimum of 12 years of data exclusivity for an approved biologic.

July 14, 2009: The House Committee on the Judiciary held a hearing on "Biologics and Biosimilars: Balancing Incentives for Innovation." The statements of the panelists are available from the Committee's website here.

June 10, 2009: The Federal Trade Commission published its report on the competitive effects of biogenerics and concluded that "providing the U.S. Food and Drug Administration (FDA) with the authority to approve [biogenerics] would be an efficient way to bring these lower-priced drugs to market." The FTC announcement is here. The report is available here.

In March 2009, congressional representatives introduced two competing bills to enable FDA approval of generic versions of biologics. These bills appeared swiftly after President Obama's 2010 budget specifically called for such a process. Although Congress has considered similar legislation in past years, given the current level of presidential and bipartisan support, enactment of a generic approval route for biologics is increasingly likely. March 11, 2009 - Representative Waxman (CA), along with Representatives Deal (GA), Emerson (MO), and Pallone (NJ), introduced the first bill, H.R. 1427 (the "Waxman bill"). To read our client alert on this proposed legislation, click here.

March 17, 2009: Representatives Eshoo (CA), Inslee (WA), and Barton (TX) introduced a competing bill, H.R. 1548 (the "Eshoo bill"). To view a table comparing the Eshoo and Waxman bills, click here.

March 26, 2009: Senator Schumer (NY) and colleagues introduced a bill identical to the Waxman bill in the Senate as S. 726.

March 9, 2009: The Boston Globe published an editorial on biogenerics linked here. Pharmaceutical industry trade organizations have taken strong positions on the legislation proposed by Waxman. BIO's position is set out here. The GPhA endorsed the Waxman bill and stated its position here.

February 27, 2009: Representative Henry Waxman presented a speech endorsing biogenerics at the Generic Pharmaceutical Association Annual Meeting. A story about the speech is here. Rep. Waxman was a co-sponsor of the 1984 Hatch-Waxman Act.

February 26, 2009: President Obama's 2010 budget included funds to support development of a biogeneric program. A related story from the Boston Globe is here.