WASHINGTON, March 12 /PRNewswire-FirstCall/ -- Proposed legislation that creates a regulatory framework to guide the approval of the first biogeneric medicines represents a critical step forward in providing more affordable treatment for millions of Americans suffering from chronic and complex conditions, David B. Snow Jr., chairman and CEO of Medco Health Solutions, Inc. (NYSE: MHS) said today.
"The investment in research and innovation over a period of many years has led to the breakthrough therapies that are available today in specialty pharmacy for the treatment of many serious diseases," said Snow. "We salute the vision of Chairman Waxman, Representative Deal and their co-sponsors, who have crafted an approach that balances the government's role for promulgating and regulating, while allowing the private sector to innovate and operate. This framework authorizes the FDA to construct an approval process that can lead to lower costs for payors and patients, while continuing to incent and reward breakthrough science."
Currently, as much as 16 percent of overall spending on so-called "specialty" medicines goes toward purchasing biotech drugs that have already lost their patent protection but, without this critical approval process, have no lower-cost generic competition. Medco estimates that generic versions of biotech medicines -- often called "biosimilars"-- could reach the market by 2013, creating a $34 billion opportunity in this new market through 2017, and significantly lowering the costs for these medicines.
"This legislation provides the FDA with the authority to ensure that we remain the world's gold standard for prescription drug safety, and extends it to a generics approval process for a new class of medicines," said Snow. "For all their therapeutic benefit, patients and payors alike are overwhelmed
|SOURCE Medco Health Solutions, Inc.|
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