Moving Toward a Biosimilars Pathway: The Lines are Drawn in Congress - The introduction of two rival bills has intensified the long-simmering debate on biosimilars regulation in the US.

Moving Toward a Biosimilars Pathway: The Lines are Drawn in Congress - The introduction of two rival bills has intensified the long-simmering debate on biosimilars regulation in the US. - BioPharm

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Moving Toward a Biosimilars Pathway: The Lines are Drawn in Congress

The introduction of two rival bills has intensified the long-simmering debate on biosimilars regulation in the US.

Jul 1, 2009
By: Brian J. Del Buono, PhD
BioPharm International
Volume 22, Issue 7

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REFERENCES

1. The Drug Price Competition and Patent Term Restoration Act of 1984. Pub. Law 98-417; 1984. Primarily codified at 21 U.S.C. § 355 et seq. and 35 U.S.C. § 271(e).

2. Biotechnology Industry Organization. 2009;Mar 11. New bipartisan, consensus bill points to right path to biosimilars. 2009 Mar 17. Aavailable from: http://bio.org/news/pressreleases/newsitem.asp?id=2009_0317_03.

3. Mixter BD. Reps. Eshoo, Inslee, Barton introduce bill to create generic biologics pathway. Pharmaceutical Law & Industry Report. 2009;19(7);318.

4. BIO. New proposed biosimilars pathway filled with potholes. 2009 Mar 11. Available from: http://bio.org/news/pressreleases/newsitem.asp?id=2009_0311_02.

5. BIO. New Senate bill takes shortcuts on path to biosimilars. 2009 Mar 26. Available from: http://bio.org/news/pressreleases/newsitem.asp?id=2009_0326_01.

6. Henson S. Rival biologics bill introduced in House. IPLaw360; 2009 Mar 17. Available from: http://ip.law360.com/print_article/92147.

7. Favole JA. J&J Co. doesn't have plans to enter 'biosimilars' market. Dow Jones Newswires. 2009 Apr 7.

8. Generic Pharmaceutical Association. GPhA statement on introduction of H.R. 1548, "The Pathway for Biosimilars Act." 2009 Mar 17. Available from: http://www.gphaonline.org/media/press-releases/2009/gpha-statement-introduction-hr-1548-%E2%80%9C-pathway-biosimilars-act%E2%80%9D.

9. GPhA. GPhA statement on the introduction of the Bipartisan Biogenerics Consensus Bill: "Promoting Innovation and Access to Life-Saving Medicine Act." 2009 Mar 11. Available from: http://www.gphaonline.org/media/press-releases/2009/gpha-statement-introduction-bipartisan-biogenerics-consensus-bill.

10. GPhA. GPhA statement on the introduction of the Bipartisan Senate Biogenerics Consensus Bill 2009 Mar 26. Available from: http://www.gphaonline.org/media/press-releases/2009/gpha-statement-introduction-bipartisan-senate-biogenerics-consensus-bill.

11. GPhA. GPhA praises President Obama's support for safe and affordable biogenerics as critical solution to America's ailing health care system. 2009 Feb 26. Available from: http://www.gphaonline.org/media/press-releases/2009/gpha-praises-president-obama%E2%80%99s-support-safe-and-affordable-biogenerics-cri.

12. GPhA. GPhA meeting focuses on biosimilars; praises Obama's support for biosimilars. World Generic Markets. 2009;8(12):12.

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