The two sides will remain at odds, too – but that hasn’t stopped legislators and government officials from tackling the issue head on. After all, many new biotech-derived products are very expensive, and those costs have started to impact the nation’s healthcare system.

In mid-August, for example, four U.S. governors filed a citizen petition with the FDA, requesting clarification of the requirements for making generic versions of insulin and human growth hormone, which are widely prescribed. These governors (from Kansas, Wisconsin, Minnesota and Vermont) are concerned about the effects of rising healthcare costs, which they claim are placing an extreme burden on their state budgets. Moreover, they said, there is a precedent: The European Agency for the Evaluation of Medicinal Products (EMEA) has already published a series of guidelines for generic biopharmaceuticals.

For instance, the European Commission approved Sandoz’ growth hormone Omnitrope for sale in April 2006. Reportedly, the FDA has been working on its own guidelines since 2000 or so, but it hasn’t revealed its progress.

According to Ajaz Hussain, Sandoz’ VP and global head for biopharmaceutical development, “The new [EMEA] regulations assess biosimilars according to standards equally stringent to those for originator products, requiring biosimilars to be proven similar to the reference product in terms of its physicochemical properties, biological activity and impurity profile. In addition, comparable clinical safety and efficacy must be demonstrated.” (For background on some of the scientific issues, see the Buzz article, “Gearing Up For Bio-Generics.”)


In mid-September 2006, congressman Henry Waxman (D-CA), of Hatch-Waxman bill fame, told attendees at the GPhA’s annual policy conference that he would introduce a bill before year’s end that would nudge the FDA to craft guidelines for the approval of generic versions of biotech therapies. “FDA has no mechanism for evaluating and approving copies of biological products. So these products are effectively given a near permanent monopoly,” he explained. “The time has come to break this monopoly.”

Acknowledging that biologics present their own set of issues, especially the challenge of proving equivalence of a generic product with a branded one, Waxman favors a “case-by-case approach for evaluating each type of product.” And he leaves it to the FDA to develop the methods for establishing such equivalence.

At the same conference, the other lawmaker forever associated with generic drugs, senator Orrin Hatch (R-UT), explained that he is also behind new legislation, and would be “more than happy to consider working” with Waxman in the next Congress to create a bill called Hatch-Waxman II. And, he emphasized, in crafting new legislation, “… we must balance incentives for both pioneer and generic drug firms… The key stakeholders need to engage in constructive discussions to talk about the scientific and legal issues facing follow-on biologics.”

True to his word, Waxman started the ball rolling a few weeks later: On September 29, Waxman and Senators Charles Schumer (D-NY) and Hillary Rodham Clinton (D-NY) introduced their “Access to Life-Saving Medicine Act,” which is intended to “establish the necessary clear, efficient abbreviated pathway for approval of generic biopharmaceuticals, ultimately saving consumers and the health care system billions of dollars.” (According to the GPhA, even a 5-10 percent reduction in biopharmaceuticals costs could amount to millions in savings.)

BIO stands by its position on this issue, emphasizing the importance of subjecting these products to “the same rigorous standards applied by the FDA for the approval of pioneer biotechnology products.” And that includes data gathered in the clinic. Above all, BIO says, in the ongoing debate on follow-on biologics, “any evaluation of whether or how to authorize such a [regulatory] pathway must fully address both how to ensure patient safety and how to maintain incentives that spur continued innovation.”

The parties involved in this debate have already been sparring for years, and making little headway. But now that governors, senators and congressmen have grabbed onto the issue, one can only hope that they will propel it forward to some sort of resolution.