Biosimilars Battle Brewing

On March 11, 2009, Reps. Henry Waxman (D-CA), Frank Pallone (D-NJ), Nathan Deal (R-GA), and Jo Ann Emerson (R-MA.), introduced into the House, the bipartisan “Promoting Innovation and Access to Life-Saving Medicine Act” (H.R. 1427)(the “LSMA”). This Bill provides an alternative to the “Pathway of Biosimilars Act” (the “PBA”), introduced by Reps. Anna Eshoo (D-Calif.), Jay Inslee (D-Wash.) and Joe Barton (R-Texas) in March of 2008 and reintroduced in the 111th Congress on March 17, 2009 (H.R.1548), a few short days after the Waxman Bill (as this article goes to press, Senators Charles Schumer (D-NY) and Susan Collins (R-Maine) introduced a bipartisan bill that closely mirrors the LSMA). The LSMA and PBA set up alternative approaches to opening up the market to a shortened approval process for generics of biologics, typically drugs based on biological macromolecules, such as antibodies. The Generic Pharmaceutical Association (GPhA), Consumers Union, and AARP threw their support behind this the LSMA. The Biotechnology Organization, as well as branded pharma, such as Eli Lilly and Company, announced approval of the PBA. This sets up a lively battle to come in the Legislature between those congressmen and women supporting the generic biologics industry and those supporting the branded biologics industry.


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