A Message from Kathleen Jaeger: FDA Needs to Support Generic Biologics

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Pharmacy Times, Volume 0, 0

It was disturbing to read recently thatGenentech decided to increase the priceof Avastin (bevacizumab), a biopharmaceuticalproduct used to treat colon cancer,to $100,000 per year. Avastin has nocompetitors, allowing Genentech to setthe price at whatever the market willbear. As the cost of this medicineincreases for patients, so will the cost toinsurers, health care programs such asMedicare and Medicaid, and the healthcare system in general.

The recent approval by the FDA ofSandoz's Omnitrope human growth hormonerepresented a significant first stepin bringing more affordable biopharmaceuticalsto the US marketplace. Thisdecision clearly demonstrates thatsound science exists to support theapproval of generic biopharmaceuticalsdespite assertions from special intereststo the contrary. It demonstrates thatgeneric companies can develop safe andeffective biopharmaceutical products. Itdemonstrates that the FDA already hasthe authority to approve such products.And it brings our nation one step closerto the day when generic versions ofexpensive biopharmaceuticals will bereadily available.

Scientific support for generic biopharmaceuticalswas further bolsteredin May 2005 with the publication of theUS Pharmacopeia's (USP) monographthat addresses product-quality standardsfor somatropin, a human growthhormone. By publishing this monograph,the USP indicated that a biopharmaceuticalproduct could be characterizedand standards established,despite the brand sector's claims tothe contrary.

Recent actions in Australia and theEuropean Union (EU) further confirmedthe science and safety of generic biopharmaceuticals.Already, generichuman growth hormone has been onthe market for nearly a year inAustralia, and the EU approved thesame medicine in April 2006. BothAustralia and the EU have approvalprocesses in place for generic biopharmaceuticals.By contrast, the UnitedStates is far behind.

GPhA strongly believes that it is possible,under the FDA's current structure,to permit approvals and marketingof a vast array of generic biopharmaceuticalswith relatively low to modestcomplexity, and to expand that systemin the coming years to permit theapproval of more complex products assound science evolves. The FDAapproval of Omnitrope supports ourposition.

For several years, the FDA haspledged to address the approval processthrough the release of a white paperalong with draft guidances on policy,chemistry, manufacturing and controls,and immunogenicity. To date, no actionhas been taken. Members of Congresshave noticed the delay. Sen Orrin Hatch(R, Utah) and Rep Henry Waxman (D,Calif) inquired why these documents, aswell as the review of an application fora generic human growth hormone,were stalled for about 3 years. The FDAresponded to their inquiry by statingthat the agency is now considering thedevelopment of broader guidance documents,even though it had flatlyrejected this approach years earlier onthe grounds of lack of industry value. Itappears that these documents arebeing delayed for political reasons, notscientific ones.

The use of biotech medicines isincreasing, and marketed biologicproducts are growing at a rate of 17%annually, with no signs of slowing.Already, biopharmaceuticals comprisea growing percentage of Medicare andMedicaid costs. Members of Congresshave recognized the problem of burgeoningcosts, with one senator notingthat, "if we don't explore prudent stepsto encouraging generic biologics, drugprices may rise so much that it wouldendanger Medicare itself."

It is time for Congress to ensure thatthe FDA will take those prudent steps.The FDA should not be denying US citizens—and the health care system—similar savings through the approval ofgeneric biopharmaceuticals.