By Donald Zuhn --
Last Thursday, Rep. Anna Eshoo (D-CA; at right) introduced a new biologics bill in the House. The bill (H.R. 5629), which would amend Section 351 of the Public Health Service Act to create a regulatory pathway for biosimilars, has been referred to the Committee on Energy and Commerce and the Committee on the Judiciary for consideration.
Rep. Eshoo's bill would specify an exclusivity period of 12 years (i.e., a generic company would have to wait 12 years after the innovator biologic is first licensed before the generic's own follow-on biologics application could be approved). The exclusivity period specified in H.R. 5629 can be contrasted with that of H.R. 1956, which was introduced by Rep. Jay Inslee (D-WA) last April, and which specifies a 14 year period of exclusivity for the innovator product.
We first learned of Rep. Eshoo's bill last month during a conference call with Biotechnology Industry Organization (BIO) President and CEO Jim Greenwood (at left) (see "BIO CEO Provides Update on Patent Reform and Follow-on Biologics Legislation - Part II"). During the conference call, Mr. Greenwood expressed a preference for Rep. Inslee's bill, in part because the details of Rep. Eshoo's bill were not yet known.
On Friday, BIO released a statement regarding Rep. Eshoo's bill, in which Mr. Greenwood commended Rep. Eshoo and Rep. Joe Barton (R-TX), a co-sponsor of the bill and the top Republican on the House Energy and Commerce Committee, for "taking a strong, bipartisan step forward toward developing a pathway for the approval of follow-on biologics." Mr. Greenwood noted that the regulatory pathway defined by H.R. 5629 contained "essential elements" needed to protect patient safety and ensure continued innovation. Among these essential elements are provisions of the bill that call for generic companies to submit clinical and immunogenicity studies, and that allow the FDA to make determinations on the interchangeability of follow-on biologics.
While Mr. Greenwood observed that Rep. Eshoo's bill "falls short of the base 14 years that has been demonstrated to be the needed period required to strike the right balance between providing incentives for innovation and follow-on product entry," he urged Congress to "pass the right bill as soon as possible." (Mr. Greenwood did not specify which of the two bills was the "right" one, but one presumes he would favor the 14 year exclusivity period of H.R. 1956.) Arguing that it was "time to place patient needs before political gamesmanship," Mr. Greenwood called for passage of a "pro-patient, pro-innovation, pro-science follow-on biologics bill."
One of The Wall Street Journal blogs also chimed in last Friday concerning H.R. 5629. Unfortunately, the Journal got a few things about the bill wrong. First, the Journal reported that the exclusivity period in the Eshoo bill was 14.5 years, rather than 12 years. Second, the article appears to have implied that the exclusivity period would run from the time the bill became law, rather than from the time the innovator biologic was approved for use. A clarification was subsequently added to the article after its author received word from Rep. Eshoo's Chief of Staff regarding the errors.
For additional information on this and other related topics, please see
• "BIO CEO Provides Update on Patent Reform and Follow-on Biologics Legislation - Part II," February 14, 2008
• "Insmed Announces National Awareness Campaign Regarding Follow-on Biologics," February 13, 2008
• "Millennium Pharmaceuticals Spent $1.28 Million on Lobbying in 2007," February 8, 2008
• "Biologics Legislation Faces Unresolved Issues," December 28, 2007
• "BIO CEO Provides Briefing on Follow-On Biologics and Patent Reform," September 18, 2007
• "Biotechs Facing New Challenges," August 13, 2007
• "Three New Biosimilars Pass EMEA Test," July 26, 2007
• "European Medicines Agency Releases Paper on Biosmiliar Medicines," July 23, 2007
• "Senate Committee Passes Biologics Legislation," July 5, 2007
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