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GPhA Statement on Introduction of H.R. 1548, 'The Pathway for Biosimilars Act'
Date:3/17/2009

rket exclusivity. Given that there is a minimal difference of less than eight months longer in the development of biopharmaceuticals when compared to traditional pharmaceuticals, there is little justification for excessively expanding exclusivity beyond the Hatch-Waxman model. Excessive exclusivity means that it will be decades before patients have access to affordable biogeneric medicines. For the countless patients who are choosing between paying for their medicines and putting food on their tables, waiting decades is simply not an option.

"Timely access to affordable biogenerics will save lives and save consumers and state and federal governments billions of dollars. The time has come for a truly workable pathway, not a pathway in name only."

GPhA represents the manufacturers and distributors of finished generic pharmaceuticals, manufacturers and distributors of bulk active pharmaceutical chemicals, and suppliers of other goods and services to the generic drug industry. Generics represent 69% of the total prescriptions dispensed in the United States, but only 16% of all dollars spent on prescription drugs. For more information about the industry, visit www.gphaonline.org.


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SOURCE The Generic Pharmaceutical Association (GPhA)
Copyright©2009 PR Newswire.
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