Follow-on Biologics: Rep. Eshoo Revising Her Bill To Be Closer To Senate Provision
This article was originally published in The Pink Sheet Daily
Executive Summary
California Democrat drops data exclusivity to 12 years, plus six months for pediatric studies, and removes requirement for FDA guidance before approval.
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Rep. Anna Eshoo, D- Calif., is reshaping her biosimilars proposal to provide brand products with data exclusivity for 12 years, plus another six months for pediatric studies. In addition to eliminating two years of additional exclusivity for a medically significant indication, the evolving H.R. 1548 drops a requirement for FDA to issue guidance before approving follow-on biologics. The changes bring the Eshoo approval pathway for biosimilars close to the one adopted July 13 by the Senate Health, Education, Labor and Pensions Committee as part of its health care reform bill (Also see "Follow-on Biologics Go Back To The Future: Senate Cmte. Endorses 12 Years of Brand Exclusivity" - Pink Sheet, 13 Jul, 2009.). That measure does not include pediatric exclusivity and Eshoo has not added HELP committee language designed to prevent ever-greening. Removing the mandatory guidance provision is a win for generics companies, who argue that market-entry of biosimilars could be significantly delayed while FDA writes guidelines. But more important to gaining passage when Eshoo brings up the proposal during Energy and Commerce Committee markup of health reform legislation (H.R. 3200) could be her decision to eliminate sections that would amend the U.S. Patent Act and limit actions for declaratory judgments. Eshoo appears to have the votes to get her measure through committee, but H.R. 3200 has no provisions for follow-on biologics, opening up the question as to whether a biosimilars amendment is germane (Also see "Follow-on Biologics Showdown In House Set For July 17" - Pink Sheet, 15 Jul, 2009.). Committee Chair Henry Waxman, D-Calif., whose biosimilars bill allows six years of exclusivity, will make the decision if the issue is raised. But the House Parliamentarian has given Eshoo a preliminary ruling that H.R. 1548, minus the patent law and declaratory judgment provisions, is germane to health care reform. A ruling on the final language will be sought before taking it to markup, a staffer notes. Sen. Sherrod Brown, D-Ohio, says he will seek to shorten the data exclusivity period in the Senate bill during floor debate (Also see "Sen. Brown Vows Floor Fight On Follow-on Biologics" - Pink Sheet, 14 Jul, 2009.). Should he fail and the House approve a bill with 12 years of exclusivity, there would be no need to take up the issue in conference committee. Differences in patent provisions would have to be resolved, however, since the HELP bill includes provisions to limit declaratory judgment action and more extensive resolution procedures. -Cathy Dombrowski ([email protected]) |