By Donald Zuhn --
Yesterday, Rep. Anna Eshoo (D-CA) (at right) provided an alternative to Rep. Henry Waxman's (D-CA) follow-on biologics bill, when she introduced the Pathway for Biosimilars Act (H.R. 1548). Rep. Waxman had introduced his own bill (H.R. 1427; the Promoting Innovation and Access to Life Saving Medicines Act) last week.
The introduction of the Eshoo bill comes as little surprise, as Rep. Eshoo, like Rep. Waxman, had introduced a similar bill during the 110th Congress. In fact, five follow-on biologics bills were introduced in the last Congress: H.R. 1038 and S. 623 (introduced by Rep. Henry Waxman and Sen. Charles Schumer in February 2007), H.R. 1956 (introduced by Rep. Jay Inslee in April 2007), S. 1695 (introduced by Senator Edward Kennedy in June 2007), and H.R. 5629 (introduced by Rep. Anna Eshoo and Rep. Joseph Barton in March 2008). Interestingly, Rep. Inslee has signed on as a co-sponsor of Rep. Eshoo's new bill, suggesting that Rep. Inslee will not be introducing his own follow-on biologics bill in the current Congress.
Much of the debate surrounding the prior follow-on biologics bills centered on the exclusivity periods provided by each bill, with H.R. 1956 providing twelve years of data exclusivity (the period of time during which a potential generic drug supplier is prevented from using an innovator's clinical trial and related data to substantiate the safety of the generic's medically equivalent drug) followed by two years of approval or market exclusivity (the period of time during which a generic drug supplier can file for, but not receive, FDA approval), S. 1695 and H.R. 5629 providing four years of data exclusivity followed by eight years of approval exclusivity, and S. 623 and H.R. 1038 providing the same exclusivity period found in the Hatch-Waxman Act (i.e., generally, five years of market exclusivity for original products and three years for some modified versions of existing drugs).
With regard to exclusivity periods, a full nine years of exclusivity separate the 5.5-year maximum provided by Rep. Waxman's bill and the 14.5-year maximum provided by Rep. Eshoo's bill. The bills also appear to have very different levels of support, with Rep. Waxman attracting three co-sponsors and Rep. Eshoo attracting 43 co-sponsors.
In a press release issued on her website, Rep. Eshoo noted that while "[b]iotechnology can lead to cures for cancer, diabetes, and AIDS, and prevent the onset of deadly and debilitating diseases like Alzheimer's, heart disease, and Parkinson's, . . . we need to preserve incentives to innovate and ensure that these therapies are safe and effective." Rep. Eshoo contends that her new bill would achieve these objectives. The press release issued by Rep. Eshoo's office also indicated that her bill had the support of "the academic and research community, patients, biotech companies, and the entrepreneurs who support the small start-up firms that form the basis of the biotechnology industry."
In response to the introduction of H.R. 1548, the Biotechnology Industry Organization (BIO) issued its own press release, in which BIO President and CEO Jim Greenwood stated that the Eshoo bill "provides patients with the right balance between innovation and competition." In contrast with its statement following the introduction of Rep. Waxman's bill, Mr. Greenwood stated that BIO was pleased to announce its support for Rep. Eshoo's bill.
• "Waxman Introduces Follow-on Biologics Bill," March 11, 2009
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