USP monograph renews biopharmaceuticals debate

Chain Drug Review, June 6, 2005

ARLINGTON, Va. -- The Generic Pharmaceutical Association (GPhA) says a new monograph from the United States Pharmacopeia shows scientific support exists for generic biopharmaceuticals.

GPhA notes USP's monograph on human growth hormone (HGH) validates the science underlying generic biopharmaceuticals and demonstrates approval of such products would yield tremendous cost savings for the nation's health care system.

Last month USP announced creation of the first monographs on somatropin, frequently referred to as HGH.

"Although the brand industry has argued biopharmaceuticals cannot be adequately characterized, this monograph clearly shows the technology and science exist to characterize some of these medicines," maintains GPhA president and chief executive officer Kathleen Jaeger.

"There is no reason to delay consumer access to affordable medicines when sound science backed by the FDA [Food and Drug Administration], MIT [Massachusetts Institute of Technology] scientists and now USP supports the approval of generic biopharmaceuticals under a shortened and less costly pathway."

Jaeger notes scientists at the FDA and MIT have acknowledged that the science exists to create and characterize glycan products and other generic biopharmaceuticals.

"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 sound science evolves," Jaeger says. "The USP monograph clearly backs up this point."

GPhA, she adds, continues to urge the FDA to release its white paper and other guidances on biologics. Although the agency announced four years ago that it would be working on such documents for insulin and growth hormone, it has yet to release such guidance.

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