Experts look at future of generics
[2008-4-14]
As science uncovers more effective biologic treatments for common diseases, biotechnology companies, policy-makers and patient advocates are debating the impact that creating generic versions of these drugs would have on the pharmaceutical industry and health care consumers.
The second annual Tuck Global Healthcare Conference at Dartmouth College yesterday focused on the future of generic biologic drugs and how establishing a regulatory framework for government approval of "biogenerics" in the United States could change the landscape of the pharmaceutical industry on a global scale.
Biologic drugs are generally injectable treatments, including vaccines, that are made from living organisms or their products, used to treat a growing number of ailments, from cancer to diabetes to rheumatoid arthritis.
However, due to the complexity of biopharmaceuticals, regulatory rules for approving generic versions have yet to be put in place. The Food and Drug Administration's drug approval process doesn't yet support biogeneric reviews, even as patents on branded biologic products expire. As a result, "The issue of biosimilars is one of the most important issues in health care," said Don Conway, director of the Healthcare Initiative at Tuck.
Attending the conference were Ally McNair, president of AARP New Hampshire, and James Leddy, president of AARP Vermont. At a conference that centered on the business implications of the debate surrounding biogenerics, McNair, Leddy and AARP Senior Legislative Representative Anna Schwamlein Howard articulated the patient perspective and delivered a strong message about the need for accessible and affordable health care for all.
"It's an access issue," McNair said in an interview after the conference. "We want people to have access to the less expensive, similar drugs sooner."
McNair and Leddy have heard the heart-wrenching stories of AARP members who are unable to afford their prescriptions that, in many cases, cost tens of thousands of dollars per year. The high cost of these drugs is "directly tied to the influence of the pharmaceutical industry in the political world," Leddy said.
AARP has endorsed the pending Access to Life-Saving Medicines Act that would establish a process through which the FDA could approve lower cost copies of biologic drugs.
Meanwhile, biotech trade organizations have endorsed a competing bill, the Patent Protection and Innovative Biologic Medicine Act, and political gridlock has ensued.
Ending the political tug-of-war is part of the mission of Divided We Fail.org, an AARP-sponsored initiative that demands elected leaders find solutions to the country's health care crisis.
AARP is focusing its efforts on helping eligible people participate in pharma-run patient assistance programs and collect economic stimulus checks from the government by filing tax returns this year, even if they normally would not.
The second annual Tuck Global Healthcare Conference at Dartmouth College yesterday focused on the future of generic biologic drugs and how establishing a regulatory framework for government approval of "biogenerics" in the United States could change the landscape of the pharmaceutical industry on a global scale.
Biologic drugs are generally injectable treatments, including vaccines, that are made from living organisms or their products, used to treat a growing number of ailments, from cancer to diabetes to rheumatoid arthritis.
However, due to the complexity of biopharmaceuticals, regulatory rules for approving generic versions have yet to be put in place. The Food and Drug Administration's drug approval process doesn't yet support biogeneric reviews, even as patents on branded biologic products expire. As a result, "The issue of biosimilars is one of the most important issues in health care," said Don Conway, director of the Healthcare Initiative at Tuck.
Attending the conference were Ally McNair, president of AARP New Hampshire, and James Leddy, president of AARP Vermont. At a conference that centered on the business implications of the debate surrounding biogenerics, McNair, Leddy and AARP Senior Legislative Representative Anna Schwamlein Howard articulated the patient perspective and delivered a strong message about the need for accessible and affordable health care for all.
"It's an access issue," McNair said in an interview after the conference. "We want people to have access to the less expensive, similar drugs sooner."
McNair and Leddy have heard the heart-wrenching stories of AARP members who are unable to afford their prescriptions that, in many cases, cost tens of thousands of dollars per year. The high cost of these drugs is "directly tied to the influence of the pharmaceutical industry in the political world," Leddy said.
AARP has endorsed the pending Access to Life-Saving Medicines Act that would establish a process through which the FDA could approve lower cost copies of biologic drugs.
Meanwhile, biotech trade organizations have endorsed a competing bill, the Patent Protection and Innovative Biologic Medicine Act, and political gridlock has ensued.
Ending the political tug-of-war is part of the mission of Divided We Fail.org, an AARP-sponsored initiative that demands elected leaders find solutions to the country's health care crisis.
AARP is focusing its efforts on helping eligible people participate in pharma-run patient assistance programs and collect economic stimulus checks from the government by filing tax returns this year, even if they normally would not.
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