Government

Generic biologicals blocked by lack of federal approval process

The FDA is working on a policy, and a new bill would create an approval mechanism.

By Doug Trapp — Posted Nov. 13, 2006

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Generic human growth hormone is already available in Europe and Australia, but Americans are facing an undetermined wait for this and other cheaper biopharmaceuticals.

So far, there is no Food and Drug Administration policy for approving generic biologicals, often called "follow-ons" in the United States and "bio-similars" in Europe.

The FDA has been formally working on a policy for about a year, but it won't be finished imminently, said FDA spokeswoman Crystal Rice. The agency had no other comment.

A bill introduced in September by Rep. Henry Waxman (D, Calif.) would establish a method for the FDA to approve generic biological drugs.

The measure, the Access to Life-Saving Medicine Act, is in response to the booming market for biological drugs and their high costs. Waxman will reintroduce the legislation next year if it doesn't pass this year, his staff said.

In 2005, sales of biologicals increased 17% to $32.8 billion, according to IMS Health, a company that tracks pharmaceutical sales. That number is expected to increase to between $60 billion and $90 billion by 2010, according to various estimates.

The FDA has approved more than 254 brand-name biological medicines for the treatment of cancer, arthritis, anemia and other diseases.

More than 300 biological drugs and vaccines are in clinical trials. Among the conditions they would treat are heart disease, Alzheimer's disease, diabetes, AIDS and multiple sclerosis, according to the Biotechnology Industry Organization, which represents more than 1,100 drugmakers and related groups in the United States and 31 other countries.

Iressa, a biologic used to treat lung cancer, costs $2,000 per month. Remicade, a treatment for rheumatoid arthritis and other inflammatory disorders, costs more than $35,000 per year, according to a statement by the bill's sponsors. Other biologicals cost $100,000 or more per year.

The European Union estimates that it will save $2.8 billion in 2006 with the introduction of just a few generic biopharmaceuticals, said the Generic Pharmaceutical Assn.

The European Medicines Agency expected at least four applications for follow-ons this year, possibly including generic insulin, said spokesman Martin Harvey Allchurch. "We should be seeing more in the years to come," he said. The agency, Europe's FDA equivalent, reviews applications on a case-by-case basis.

The safety question

While most brand-name biopharmaceuticals are licensed as "biological products" under the Public Health Service Act, some are approved as "new drugs" under the Federal Food, Drug and Cosmetic Act.

Choosing an approval pathway for generics is one unresolved issue for the FDA. Waxman's bill would amend the Public Health Service Act to permit follow-on approvals.

Brand-name biologicals must go through clinical trials to prove their safety and effectiveness and to quantify their characteristics. The European Medicine Agency's policy, which took effect one year ago, requires more clinical trials than the Waxman bill would, said Andrea Hofelich, spokeswoman for the Generic Pharmaceutical Assn. The group backs Waxman's measure as a way to bring "safe, effective and affordable biopharmaceutical medicines to consumers."

The difference between the bill and the EU policy concerns the Biotechnology Industry Organization. It responded to the legislation by recommending that the FDA continue to require the same level of scrutiny for generic biologicals as for the originals.

That doesn't mean that the organization demands that follow-on makers repeat every single step of their brand-name predecessors -- only enough of them to establish that the generic product is an exact copy of and works exactly like the original biological medicine.

"It is important for safety's sake that if a pathway is to be created for follow-on biologicals, the sponsors of those applications bring to the FDA a complete set of clinical data that demonstrate that, in fact, that molecule is the same and can be just as safe and be just as effective," said Jim Greenwood, president and CEO of the Biotechnology Industry Organization, at a September conference on biotechnology.

When people ask Greenwood why biological drugs are so expensive, he tells them the first transatlantic phone call cost $100 a minute. That money was reinvested into better technology, which gradually reduced the cost of the call to today's $1 per minute, he said.

If regulators had stepped in early on, Americans would still be calling overseas using hand-crank phones, said Greenwood, a former Pennsylvania legislator who spent 12 years in the U.S. House.

But Greenwood said he wasn't optimistic that follow-on companies would bring a windfall of savings because of the complicated, expensive research and production involved.

"It's very unlikely that we'll see the kinds of reductions in the biotech sector from competitive similars as we have in the pharmaceutical one," he said.

Starting a biotech business is an arduous, expensive enterprise, Greenwood said. Companies are lucky to survive long enough to be able to spend the millions needed for clinical trials, he added.

The Generic Pharmaceutical Assn. believes the FDA's existing regulations allow approval of follow-ons of less complex molecules, such as insulin.

Until the FDA acts, the United States is falling behind its counterparts overseas, the association states. Generic human growth hormone has been on the market in Australia since 2005 and costs 25% less than the brand, the group notes.

The FDA is two years overdue on delivering a white paper on generic biotech drugs to Congress, according to the generics organization. "Obviously there's something going on behind the scenes that's stopping this from going forward," Hofelich said.

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ADDITIONAL INFORMATION

A new path for FDA approval?

Rep. Henry Waxman (D, Calif.) introduced HR 6257, the Access to Life-Saving Medicine Act, in late September. It would:

  • Allow the secretary of Health and Human Services to approve generic biopharmaceuticals, known as follow-ons, that are comparable to brand-name biologicals.
  • Demand follow-ons share the principal molecular structural features and same mechanism of action as the brand-name biologicals.
  • Give the secretary of Health and Human Services the discretion -- on a case-by-case basis -- to determine what studies are needed for follow-ons.
  • Authorize tax credits for studies establishing "interchangeability," or the ability to substitute follow-ons at the pharmacy level.
  • Give the first applicant for a generic alternative an exclusive marketing period for the follow-on.
  • Give patent holders 45 days to file a patent infringement suit.

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