U.S. Lawmakers Introduce Second Follow-On Biologics Bill

U.S. Lawmakers Introduce Second Follow-On Biologics Bill

Representatives Anna Eshoo, Jay Inslee, and Joe Barton have introduced the second bill in as many weeks that would allow the FDA to approve a biological product as being “biosimilar.” The “Pathway for Biosimilars Act” (H.R. 1548), which was introduced in Congress on March 17, would amend the Public Health Services Act to establish a new market for generic version of biologics. Not be confused with H.R. 1427, a competing follow-on biologics bill introduced in Congress on March 11 by Rep. Henry Waxman, the “Pathway for Biosimilars Act” calls for 12 years of market exclusivity for biologic products, including “an additional two years of exclusivity for the approval of a medically significant new indication that, if approved, would be a significant improvement over currently available therapies for the treatment or prevention of a disease.” This differs from Waxman’s proposal, which calls for just five years of market exclusivity for an original product and three years for modifications of a previously approved product.

In addition to the above, Eshoo’s legislation includes a set of measures for identifying relevant patents and resolving any patent disputes before the expiration of the products exclusivity period.

This act has been referred to the Committee on Energy and Commerce, and the Committee on the Judiciary. A PDF of H.R. 1548 can be downloaded by clicking on the following link: http://eshoo.house.gov/images//pathway%20for%20biosimilars%20act.pdf.    

The attorneys in the firm’s Life Sciences Practice Group will monitor this legislation and will involve their colleagues in the firm’s Federal Relations Group in the Washington, D.C., office if you have any interest in becoming more involved in the development of this or any other legislation pending before Congress. For more information regarding this Act and its possible effects on the biotechnology industry, please contact Todd Vare (317-231-7735 or todd.vare@btlaw.com) in Barnes & Thornburg LLP’s Life Sciences Practice Group.

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