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Broad Stakeholder Coalition Concludes that the 'Pathway for Biosimilars Act' Fails to Ensure Timely Access to Safe, Affordable Biogeneric Medicines for Patients
Date:3/14/2008

WASHINGTON, March 14 /PRNewswire-USNewswire/ -- The Coalition for a Competitive Pharmaceutical Market (CCPM) -- the organization representing a broad range of pharmaceutical stakeholders, including large national employers, insurers, pharmacies and generic drug manufacturers -- strongly urges Congress to develop legislation that will provide safe, effective and affordable biogenerics to consumers. This legislation must provide an appropriate balance between innovation and access to affordable biogenerics through competition.

The Pathway for Biosimilars Act will not bring timely patient access to safe and affordable biogeneric medicines as it fails to provide for a workable approval pathway or promote much needed competition in the biopharmaceutical marketplace. Under the Pathway for Biosimilars Act, it will be at least a decade before patients have access to more affordable biopharmaceuticals.

"It is widely acknowledged that the science exists to permit FDA to approve safe and effective comparable and interchangeable biogeneric products," said Katie Huffard, Executive Director of CCPM. "We urge Congress to create a workable pathway that relies on the FDA's scientific expertise to assure safety and effectiveness -- a pathway that ensures no undue delays to market entry and enhanced patient choice."

CCPM has worked diligently in a bipartisan fashion to help pass legislation that provides patients and their physicians access to safe, effective biogeneric medicines. CCPM supports passage of legislation this year that achieves these goals and will continue to work for balanced legislation this year and look for opportunities for compromise. To ensure that consumers, businesses and our health care system truly benefit from biogenerics legislation, Congress must pass a bill that:

-- Creates a workable FDA approval process for both comparable and interchangeable products

-- Provides for timely resolution of patent disputes

-- Encourages innovation by both brand and generic companies without requiring excessive, unprecedented, and unjustified market exclusivity, data exclusivity or patent extension provisions

CCPM urges members of the House of Representatives to return to the fundamental principles embodied in the bipartisan Access to Life Saving Medicines Act. This legislation, which is supported by consumer and patient advocates, employers, health plans, pharmacies and others, would create a meaningful and workable FDA approval pathway without excessive barriers to timely consumer access.

"American purchasers of pharmaceuticals are looking for action, but the bill must appropriately balance innovation and competition." said Huffard. "Congress has the ability to pass a landmark bill that will make a difference in the health of countless Americans. We well recognize that compromise will be required, but the Pathway for Biosimilars Act fails to make meaningful steps in this regard. We urge Members of Congress from both parties to ensure the pathway works for patients, employers, health plans as well as brand and generic industries."

CCPM supports public policies that facilitate timely access to affordable pharmaceuticals. Visit http://www.competitiverx.com for more information and a list of CCPM members.


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SOURCE Coalition for a Competitive Pharmaceutical Market
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