Generic Approval

Biotechnology comes of age.

WHEN YOU want to buy a bottle of painkillers, you usually have a few choices -- the branded stuff, which comes at a slight premium, or the generics, cheaper but identical in all but label. Generics are great for the consumer; they are inexpensive, and once the makers of generic drugs can legally produce off-brand medications, they drive down prices for the branded stuff, too. But for a class of particularly expensive drugs -- biopharmaceuticals, which are derived from living organisms -- the Food and Drug Administration lacks the regulatory framework to quickly approve generic drug companies' alternatives, known as "follow-on biologics" or "biosimilars."

The biotechnology industry is growing up. Some of the oldest biotech patents -- covering the manufacture of complex proteins such as insulin and human growth hormone -- have expired or are about to do so. Enter the generics industry, champing at the bit to start producing in the United States. In the past, concerns over the ability of generic drug firms to reproduce name-brand biopharmaceuticals prevented the design of a track for approving their cheaper versions. Biopharmaceuticals are often so complex that it is difficult to show that a generic manufacturer can make an equivalent product. But makers of generic drugs have taken steps to produce biopharmaceuticals abroad, and the European Union has set up its own regulatory system for approving follow-on biologics.

Now Sen. Edward M. Kennedy (D-Mass.), chairman of the committee that oversees health policy, is working with a group of senators on a proposal to add a relevant approval structure to a sprawling FDA bill that passed the Senate last month. Before the amendment is offered in conference, it will be marked up in committee later this month.

There should be a regulatory framework for the expedited approval of follow-on biopharmaceuticals -- as long as the FDA can ensure to a reasonable degree that the alternative treatments are safe and effective. What that entails is a matter of considerable debate. The brand-name biotechnology industry wants a requirement that clinical trials be conducted before any generic follow-on is approved. The generics industry more persuasively argues that the FDA should be given greater latitude to design approval requirements on a case-by-case basis, which almost certainly would include clinical trials of various sizes. This is a flexible approach that would ensure speedy approval when possible and that could adjust to changing science.

There is also significant disagreement over how to protect biotech firms' intellectual property rights and maintain sufficient incentives for innovation. Most important is that generics firms be allowed to begin the approval process early on. The system should be geared to allow follow-on biopharmaceuticals to enter the market as soon as an appropriate period of exclusivity for the brand-name company ends.