Senate Introduces Bipartisan Bill on Biosimilars

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ePT--the Electronic Newsletter of Pharmaceutical Technology

The US Senate introduced a bipartisan bill (S. 726) on Mar. 26, 2009, which establishes a regulatory pathway for approval of biosimilars.

The US Senate introduced a bipartisan bill (S. 726) on Mar. 26, 2009, which establishes a regulatory pathway for approval of biosimilars. The bill, “Promoting Innovation and Access to Life-Saving Medicine Act'” was introduced by Senators Charles Schumer (D-NY), Sherrod Brown (D-OH), Susan Collins (R-ME), Mel Martinez (R-FL), and co-sponsored by other Senators.  Last month, the House also introduced a bipartisan bill (HR 1427) for establishing a regulatory route for biosimilars.

A key provision in the Senate bill is to establish five years of market exclusivity for a biologic product from the time the brand-name drug was approved. The bill also establishes a procedure for resolution of patent disputes before a biosimilar is approved and establishes penalties for failure to litigate patents in a timely fashion.

“It’s past time we created a way for generic versions of these expensive drugs to come to market,” said Schumer in a press release. “We have a bipartisan plan that we know consumers will support and we believe the President will, too. The savings reaped from this will be a down payment on healthcare reform,”

The Biotechnology Industry Organization (BIO), the trade association representing biotechnology companies, was critical of the proposed legislation as it is with the House measure. “While well-intentioned, the bill introduced today by Senators Schumer, Brown, Collins, and Martinez follows its companion bill in the House (HR 1427, ‘The Promoting Innovation and Access to Life-Saving Medicine Act’) through the looking glass to a world of biosimilars that would jeopardize patient safety and undermine future medical breakthroughs,” said BIO President and CEO Jim Greenwood in a Mar. 26 BIO press release.

BIO disagrees with the time period allowed for exclusivity for brand-name biologics under the bill, the use of certain language that it says would discourage FDA from conducting certain clinical trials for a biosimilar, and information-disclosure requirements by biologics manufacturers.


“The bill unfairly tilts the playing field toward biosimilars manufacturers,” said Greenwood in the Mar. 26 press release. “This legislation provides for less data exclusivity than traditional pharmaceutical drugs currently receive under the Hatch-Waxman regime even though every credible study on this issue has found that biologics will need greater data exclusivity than traditional drugs to ensure future medical breakthroughs,” he said. “Additionally, innovators would be required under the bill introduced today to share detailed information about every applicable patent to biosimilar manufacturers, making it easier for the biosimilar company to bypass valid patents.  Innovators, on the other hand, would have no ability to receive relevant information from the biosimilar manufacturer about the molecules, ingredients, and processes they use to create the biosimilar.”

Instead, BIO endorses another biosimilar bill, HR 1548, “The Pathway to Biosimilars Act.” That bill was introduced in March 2009 by Representatives Anna Eshoo (D-CA), Jay Inslee (D-WA), and Joe Barton (R-TX). “The Eshoo-Inslee-Barton bill establishes parity with the outcomes of the Hatch-Waxman regime developed for traditional pharmaceuticals, balancing the need to increase access, lower costs, ensure drug safety and promote continued biomedical breakthroughs,” said Greenwood in a Mar. 17, 2009 BIO press release. “At the same time, the bill recognizes the fundamental differences between biologics and traditional pharmaceuticals.”

With regard to the Senate bill, Sens. Schumer and Collins said they are looking forward to moving forward with negotiations on the proposed biosimilar legislation as Congress considers broader health reform. In particular, they mentioned working with Sen. Edward Kennedy (D-MA), chairman of the Senate Committee on Health, Education, Labor and Pensions, to develop a pathway based on their legislation. In 2007, Kennedy was critical of a bipartisan group of senators that reached a compromise on generic biologics, according to the Senate press release. Several aspects of current Senate bill include measures from that compromise, including providing FDA full discretion to determine what studies are necessary to establish that a biogeneric is as safe and effective as the original product, said the Senate release.