• E-mail
• Print
• Comment
• Font Size
• Digg
• del.icio.us
• Discuss article

New Drug Approval Raises Hope for Cheaper Biotech Medicine

Posted on: Friday, 9 June 2006, 06:00 CDT

SAN JOSE, Calif. _ When federal regulators approved a new version of a popular growth-hormone drug last week, some people saw a big crack develop in the wall that has protected biotechnology products from cheaper imitations.

Until now, there have been few if any low-cost copycat versions of biotech drugs, leaving many patients who take such medicine saddled with staggering pharmacy bills.

Biotech companies have largely blocked the sale of imitations, arguing that the drugs are unproven and could be unsafe.

"This is a very serious potential issue," said Matthew Gardner, president of BayBio, which represents biotech firms in the Bay Area.

But patient advocates claim consumers are being hurt by not having more access to biotech copies. That's why they're hailing the approval of Omnitrope, a new version of growth hormone, as great news for people like 9-year-old Oliver Young of Larkspur, Calif. He takes growth hormone to counteract a genetic disorder called Prader-Willi syndrome, which can cause short stature, learning problems and speech defects, among other problems.

No price has been set for Omnitrope. But it is widely expected to be at least 25 percent cheaper than current growth-hormone drugs. They can cost $20,000 a year, with some insurers requiring patients to pay about half that themselves.

"Coverage varies dramatically, from families who have small to minimal co-payments to others who are paying $800 a month," said Oliver's mom, Wendy Young, who runs a Prader-Willi support group. "It's better for everyone if ultimately this medicine becomes less expensive."

Generic versions of traditional, chemically synthesized drugs are common. The U.S. Food and Drug Administration routinely permits generic copies to be sold once the patent on the original expires. And because generics don't have to undergo the same rigorous testing as the original, they cost less to make and can be priced lower.

The savings to consumers can be substantial. Once a second generic version of a drug hits the market, it usually sells for about half the original's price and multiple copies often cost 80 percent less, according to the FDA.

But biotech executives have largely objected over the years to generic versions of their medicines. Because biotech drugs are made through biological processes and tend to be complicated to manufacture, the industry has long claimed it's unwise to assume generic versions are as safe and effective as the original. Consequently, Congress and the FDA have resisted allowing biotech copies.

Nonetheless, with patents for many biotech drugs expiring soon, generic manufacturers are pressuring the government to ease those restrictions.

In July 2003, Sandoz, a generic drug maker owned by Novartis of Switzerland, asked the FDA to let it sell Omnitrope. The drug, modeled after Pfizer's market-leading Genotropin, generally is regarded as a relatively easy biotech product to make. And because much already is known about how growth hormones work, Sandoz argued that the FDA should approve it quickly.

But the idea was opposed by the Biotechnology Industry Organization and some of its members, notably Genentech of South San Francisco, which sells a different kind of growth-hormone drug. The objections prompted the FDA to take its time in reviewing Omnitrope. Sandoz had to get a federal court order in April this year to force the agency to make a decision.

In approving Omnitrope on May 30, the FDA insisted it wasn't inviting a flood of biotech generics.

For one thing, it said Omnitrope technically wasn't a generic, which would have required it to be biologically equivalent to Genotropin. Instead, the FDA said, Omnitrope was a "follow-on" medicine, meaning it only needed to be similar.

Moreover, the FDA said the law generally barred it from permitting biotech imitations. It noted that growth-hormone and insulin products are governed by the Federal Food, Drug and Cosmetic Act, which permits copies. But vaccines and most other biotech drugs are under the Public Health Service Act, which would have to be amended to allow for generics, the FDA said. Even so, the FDA's action is viewed by some as opening the door for biotech imitators.

Omnitrope is the first FDA-approved biotech copy not produced by the original drug's manufacturer and Sandoz intends to market it as a generic. Moreover, Rep. Henry Waxman, D-Calif., is considering introducing an amendment to the Public Health Services Act this summer, according to his staff.

Waxman had been waiting for the FDA to act on Omnitrope before introducing the measure. By approving Sandoz's drug, his staff said, Waxman believes the agency now has provided evidence that generic manufacturers can make biotech copies as good as the original.

Passing such an amendment could prove difficult, given the opposition of politically influential drug firms.

"When and if this comes to Congress, our voices will be heard," said Walter Moore, Genentech's vice president of government affairs.

But with consumers clamoring for cheaper drugs, other experts say, many lawmakers may be inclined to make it easier for biotech generics to be sold.

"There is a lot of pressure in Congress to provide a pathway for eventually these kinds of products to be approved,' said Alan Mendelson, a Menlo Park, Calif., lawyer with Latham & Watkins, who counsels many biotech companies.

"Hopefully Congress hears the call," said Kathleen Jaeger, chief executive officer of the Generic Pharmaceutical Association. "There is so much potential savings to be garnered by having generics in the marketplace."

___

(c) 2006, San Jose Mercury News (San Jose, Calif.).

Visit MercuryNews.com, the World Wide Web site of the Mercury News, at http://www.mercurynews.com.

Distributed by Knight Ridder/Tribune Information Services.

For reprints, email tmsreprints@permissionsgroup.com, call 800-374-7985 or 847-635-6550, send a fax to 847-635-6968, or write to The Permissions Group Inc., 1247 Milwaukee Ave., Suite 303, Glenview, IL 60025, USA.

Source: San Jose Mercury News

More News in this Category