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Washington�Brand-name drug makers have a lock on manufacturing biologics, a group of lucrative, protein-based drugs made from living cells and used to treat such diseases as cancer and diabetes. But the clock is ticking on many of their patents. And generic manufacturers are anxious to jump into the market as those patents�estimated by industry analysts to be worth about $10 billion�expire over the next few years. Now, it’s up to federal regulators and Congress to decide whether the generic companies have the know-how to safely replicate the science behind biologics, or whether the drugs are best left in the hands of brand-name makers. “This is one of those epochal moments,” said Paul Kim, a food and drug counsel in Boston-based Foley Hoag’s Washington office who represents biologic drug makers Amgen Inc. and Genzyme Corp. It could “redraw the competitive lines.” Regulators and members of Congress are under pressure to act. In the last few months, the Food and Drug Administration has been bombarded with petitions from brand-name companies trying to prevent generic versions of their drugs. In response, the FDA, which had said it would publish scientific guidelines for manufacturing generic biologics by this summer, has delayed their release. And the Senate Judiciary Committee, chaired by Orrin G. Hatch, R-Utah, held a hearing on the issue June 23 as a warm-up for future legislation. Some of the top names on both sides of the drug industry are involved, including brand-name companies such as Pfizer Inc. and Amgen, the self-described world’s largest biotechnology company, and generic manufacturers like Barr Laboratories Inc. Not surprisingly, they have lined up an impressive array of lawyers and lobbyists. Among the firms are Hogan & Hartson of Washington, Ropes & Gray of Boston and Sidley Austin Brown & Wood. In-house lobbyists from the Biotechnology Industry Organization (BIO) and the Generic Pharmaceutical Association (GPhA) are also working on the issue. “Clearly, this is one of the top priorities of the trade association,” said Kathleen Jaeger, chief executive officer of the generics association, which is lobbying FDA officials, state governments, consumer groups, health care providers, insurance companies and corporate employers on the issue. The activity is just as intense on the other side. BIO was one of the first to lobby the FDA to dissuade it from approving generic, or what BIO calls “follow-on,” biologics. And in the last year, Gregory Glover, a D.C.-based Ropes & Gray partner who represents brand-name pharmaceutical companies, has given talks at several conferences attended by FDA representatives and congressional staffers, telling them that generic biologics will not be suitable for the market. “There is almost no way for two different manufacturers to make the same [biologic] product,” Glover argues. Biologics are usually administered by injection at hospitals and doctors’ offices, and are used to treat illnesses ranging from multiple sclerosis to diabetes. Amgen, for instance, produces two well-known biologic drugs, Epogen and Neupogen, which are used to treat patients with life-threatening diseases such as kidney disease and cancer. The decision to pull in legal and lobbying talent is a sign of just how much is at stake for the companies. In 2003, biologics was a $33 billion market-a fourfold increase from just 10 years ago. Recognizing the potential, the generic industry is hoping for a law similar to 1984′s Hatch-Waxman Act. That law, an amendment to the Food, Drug, and Cosmetic Act, shortened the approval process for the generic manufacturing of what the experts refer to as “small-molecule drugs”-drugs usually administered in tablet form. Under the law, generic drugs are approved by the FDA without the manufacturers having to do their own independent clinical testing on the products. Instead, they can rely on the original data that show the drugs’ safety and effectiveness-saving the generic companies significant time and money. Biologics, however, are regulated by another law, the Public Health Service Act, which does not explicitly authorize generic versions. Many industry insiders say that Congress would have to enact a law authorizing the FDA to approve these types of follow-on drugs. “The agency ought to be setting up a system to basically tell everyone what is required,” said William Schultz, a partner at Zuckerman Spaeder of Washington who is counsel for the GPhA.

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