FDA MAKES PROGRESS ON GENERIC BIOTECH APPROVALS

JULY 01, 2006

The FDA's approval of Sandoz's Omnitrope human growth hormone opens the door for what some are calling a new wave of generic biotech products. Omnitrope—a generic version of Pfizer's Genotropin—is the first "follow-on" biotech drug to earn approval by the FDA. Sources indicate that more products like these will come under consideration by the agency soon.

With more than $10 billion worth of biotech products in line to lose patent protection over the next 5 years, officials at the Generic Pharmaceutical Association (GPhA) called the FDA's approval of Omnitrope "a significant first step in bringing more affordable biopharmaceuticals to the US marketplace."

GPhA President and CEO Kathleen Jaeger noted that, while the United States has been debating the manufacture of generic biopharmaceuticals, patients in other countries are already enjoying access to more affordable generic biopharmaceutical products. FDA's Omnitrope decision "brings our nation one step closer to the day when generic versions of expensive biopharmaceuticals will be readily available?to help dramatically lower America's health care costs," she said.

Although Jaeger said that GPhA officials believe that the FDA already has sufficient legal authority to approve safe and effective generic biopharmaceuticals, she added that her group will continue to press for new federal legislation to codify the FDA's authority to approve generic biotech products.




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