Follow-On Grudge Match: The Round One Scorecard In Waxman vs. Eshoo
Executive Summary
Two versions of biosimilars legislation are now before the House, and the question is how much, if any, compromise will be needed to get a measure approved on that side of Capitol Hill
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Two versions of biosimilars legislation are now before the House, and the question is how much, if any, compromise will be needed to get a measure approved on that side of Capitol Hill. As chairman of the House Energy and Commerce Committee, Henry Waxman, D-Calif., has the upper hand in that he can set the agenda and hold hearings and markups on his generic-friendly H.R. 1427 (1 'The Pink Sheet,' March 16, 2009, p. 4). But committee member Rep. Anna Eshoo, also a California Democrat, introduced her bill with 43 co-sponsors. These include the committee's Ranking Republican, Joe Barton, Texas, and 11 other panel members - five Democrats and six Republicans. Among them is Jay Inslee, D-Wash, who sponsored his own legislation last year. Health Subcommittee Chairman Frank Pallone, N.J., and subcommittee Ranking Republican Nathan Deal, Ga., are co-sponsors on H.R. 1427, along with Rep. Jo Ann Emerson, R-Mo. Committee Chairman Emeritus John Dingell, Mich., is still studying the issue. Along party lines, 26 Democrats and 18 Republicans are supporting Eshoo's H.R. 1548; last year's essentially identical version ended up with number of co-sponsors: 43. Twenty-six Democrats is a large number of co-sponsors for a bill opposed by their party's leadership, but even that swing would still leave Eshoo and her supporters 20 votes short of a majority, assuming a party-line vote by everyone else. Supported by the Biotechnology Industry Organization, the Eshoo bill would: provide at least 12 years of data exclusivity for brand biologics, with an additional two years allowed for approval of a medically significant new indication; specify the studies to be included in an application, unless FDA provides a waiver; and require the biosimilar sponsor to show that its product is biosimilar for each condition of use allowed for the reference product. The interchangeability provisions of H.R. 1548 set several more requirements than those in H.R. 1427, including that the follow-on be biosimilar to the reference product plus previously approved interchangeable biosmilars. Neither bill specifies that interchangeable products could be substituted for the reference product (see 2 (Also see "Biosimilar Interchangeability Does Not Create Substitution Under House Bills" - Pink Sheet, 23 Mar, 2009.) ). - Cathy Dombrowski ([email protected]) |