FDA MAKES PROGRESS ON GENERIC BIOTECH APPROVALS

Pharmacy Times, Volume 0, 0

The FDA's approval ofSandoz's Omnitropehuman growth hormoneopens the doorfor what some are callinga new wave ofgeneric biotech products. Omnitrope—a generic version of Pfizer'sGenotropin—is the first "follow-on" biotech drug to earn approvalby the FDA. Sources indicate thatmore products like these willcome under consideration by theagency soon.

With more than $10 billion worthof biotech products in line to losepatent protection over the next 5years, officials at the GenericPharmaceutical Association (GPhA)called the FDA's approval ofOmnitrope "a significant first step inbringing more affordable biopharmaceuticalsto the US marketplace."

GPhA President and CEO KathleenJaeger noted that, while the UnitedStates has been debating the manufactureof generic biopharmaceuticals,patients in other countries arealready enjoying access to moreaffordable generic biopharmaceuticalproducts. FDA's Omnitrope decision"brings our nation one step closerto the day when generic versionsof expensive biopharmaceuticals willbe readily available?to help dramaticallylower America's health carecosts," she said.

Although Jaeger said that GPhAofficials believe that the FDA alreadyhas sufficient legal authority toapprove safe and effective genericbiopharmaceuticals, she added thather group will continue to pressfor new federal legislation to codifythe FDA's authority to approvegeneric biotech products.