GPhA Says USP Monograph Shows Scientific Support for Generic Biopharmaceuticals, USA

Main Category: Pharma Industry / Biotech Industry
Article Date: 08 May 2005 - 0:00 PDT

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The Generic Pharmaceutical Association (GPhA) today said that the US Pharmacopeia's (USP) new monograph on human growth hormone validates the science underlying generic biopharmaceuticals and shows that biopharmaceuticals can be characterized. Approval of generic biopharmaceuticals would yield tremendous cost savings for America's healthcare system.

"Although the brand industry has argued that biopharmaceuticals cannot be adequately characterized, this monograph clearly shows that the technology and the science exist to characterize some of these medicines. USP's action today further supports the establishment of an abbreviated approval process for generic biopharmaceuticals," said GPhA President and CEO Kathleen Jaeger. "There is no reason to delay consumer access to affordable medicines when sound science -- backed by the FDA, MIT scientists, and now USP -- supports the approval of generic biopharmaceuticals under a shortened and less costly pathway."

At a scientific public forum held in February 2005, scientists from the Food and Drug Administration and MIT acknowledged that the science exists to create and characterize glycan products and other generic biopharmaceuticals, which are generally large protein molecules derived from living cells. Examples include insulin, human growth hormone, antibiotics, and monoclonal antibodies. The release of USP's monograph, which addresses product standards for somatropin, a human growth hormone, today further bolsters support for the science.

"It is possible to permit approval and marketing of a vast array of generic biopharmaceuticals with relatively low to modest complexity, and to expand that system in the coming years to permit the approval of more complex products as the sound science evolves," said Jaeger. "The USP monograph clearly backs up this point."

GPhA is continuing to urge the FDA to immediately release its white paper and agency guidances on biologics, which would provide timely advice to the industry. Four years ago, FDA announced that it would be working on the agency guidelines for insulin and human growth hormone, but the agency has yet to release them.

GPhA also noted that there is an economic need for more affordable versions of biopharmaceuticals. Because of their exceedingly high costs, biopharmaceuticals will consume a greater percentage of healthcare expenditures in the future and substantially burden health care purchasers, including the federal government, employers and consumers.

For example, the average cost to a major U.S. employer for a one-day supply of biopharmaceutical drugs is $45, while traditional drugs cost an average of $1.66 per day. Today, generic medicines can cost up to 80% less than their brand counterparts and save consumers billions of dollars each year. Affordable biopharmaceuticals, even if they represented only a modest savings of 10% to 20%, would create billions of dollars in savings for consumers, the government and healthcare providers, GPhA said.

"It's time for the Pharmaceutical Research and Manufacturers of America/Biotechnology Industry Organization to stop blocking consumer access to affordable biopharmaceuticals. These delay tactics are harming the millions of Americans who need access to affordable health care," Jaeger said.

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 53% of the total prescriptions dispensed in the United States, but less than 12% of all dollars spent on prescription drugs. For further information, please contact GPhA at 703-647-2480, or visit our web site at http://www.gphaonline.org.

For USP's information - CLICK HERE.

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