The science to support the approval of generic versions of biopharmaceutical products in the United States no longer seems to be the key question. Rather, the question appears to be whether Congress and the US Food and Drug Administration (FDA) will have the resolve to open the floodgates on what could amount to billions of dollars in cost savings on these expensive therapies.
To be sure, there has been much smoke, but little fire. In February of this year, the architects of the US generic pharmaceutical industry implored FDA to take immediate steps to clarify the regulatory requirements for generic versions of insulin and human growth hormone (HGH). Senator Orrin Hatch (R-Utah), and Congressman Henry A. Waxman (D-California), in a letter to Acting FDA Commissioner Andrew C. von Eschenbach, M.D., noted that "the time has come for FDA to issue the guidance documents on the approval requirements for insulin and HGH [human growth hormone]. It is our strong belief that insulin and HGH are two products that could be separated from the development of a larger regulatory framework because they do not raise the same scientific and regulatory issues as biological products." The letter went on to argue that "There simply is no excuse—scientific, legal or otherwise—for FDA to continue to delay the release of these guidance documents." FDA responded in part, that it "has decided that it would be more appropriate to publish guidances that are more broadly applicable to follow-on protein products (FOPPs)."When will these guidances be forthcoming? No one knows for sure. Meanwhile, the European Medicines Agency (EMEA) continues to forge ahead. In February and March of 2006, EMEA released final guidelines for generic versions of insulin, somatropin (HGH), granulocyte colony-stimulating factor (GCSF), and erythropoetin. In April 2006, EMEA approved its first generic HGH (Omnitrope), and in May, its second (Valtropin). German consumers are now able to obtain Omnitrope at a discount of 20% when compared with the branded drug. Australian citizens have already had access to a generic HGH since November 2005. In stark contrast, Sandoz's US Omnitrope application still (as of this writing) languishes at FDA despite the US District Court's April 10 ruling, which compels prompt FDA action and roundly criticizes FDA for its failure to act in a timely manner.
As we have seen in the past with conventional pharmaceuticals, generic competition stimulates innovation. Without generic competition, the US is at risk of losing its position of leadership in biopharmaceuticals, and consumers continue to pay more than necessary because generic competitors have no functional mechanism to develop and receive approval for more affordable versions of these drugs.
The US can and should be moving forward on a process for approving generic biopharmaceuticals with a sense of urgency driven by the potential for saving billions of dollars for consumers.
Charles E. DiLiberti is vice president of scientific affairs at Barr Laboratories, Inc., 400 Chestnut Ridge Road, Woodcliff Lake, NJ 07677, [email protected]