Bill seeks OK for generic biological drugs

Critics say the estimated savings won't pan out.

By Doug Trapp — Posted March 12, 2007

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A House bill seeks to reproduce the savings of generic drugs in the market for biopharmaceuticals.

The Access to Life-Saving Medicine Act was reintroduced Feb. 14 by Rep. Henry Waxman (D, Calif.). The bill has six co-sponsors, including a Republican. Waxman introduced a similar measure last fall, but it didn't clear committee. Sen. Charles Schumer (D, N.Y.) introduced a companion bill Feb. 15 with five co-sponsors, including two Republicans.

Unlike the European Union, the U.S. lacks a pathway for approving generic biologicals, even though several widely used biologic drugs have expired patents. Others have patents expiring in upcoming years.

Waxman said the bill would give the Food and Drug Administration the necessary tools to approve safe generic biologicals. "We learned 22 years ago that generic drug competition brings consumers affordable, safe and effective medicines."

The measure's supporters say it could save the federal government billions. Medicare Part B could save $14 billion in the next decade with generic biologicals, says a study released in January by the Pharmaceutical Care Management Assn., a national association of pharmacy benefit managers.

But the Biotechnology Industry Organization says the study overestimates potential savings, in part because it models the savings on the experience of regular generic drugs. It also fails to account for newer biologics replacing today's popular biologics in the market, said BIO President and CEO Jim Greenwood.

The FDA will release scientific principles for the approval of generic biologicals soon, agency spokesman Ayse H. Yeaton said.

The Generic Pharmaceutical Assn. is skeptical that the agency will act quickly, said spokeswoman Andrea Hofelich. The FDA promised approval guidelines years ago, she said.

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Biogenerics boost

The Access to Life-Saving Medicine Act would:

  • Authorize the Health and Human Services secretary to approve abbreviated applications for generic versions of biopharmaceuticals that are comparable to the original drugs.
  • Grant the secretary the authority to determine what studies, if any, are needed to establish comparability.
  • Allow applicants to attempt to establish interchangeability, reproducing the same clinical results as the original drug.
  • Require the secretary to rule on applications within eight months of submission or within 180 days after the application is accepted for filing.

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Big bucks for biologics

The market for biologic pharmaceuticals continues to expand.

  • U.S. health care biotech revenues have increased from $8 billion in 1992 to $50.7 billion in 2005.
  • The FDA approved 38 new biologicals or vaccines in 2005, including three therapies for diabetes and cancer, bringing the total to 366.
  • More than 400 biologic drugs for more than 100 diseases are in clinical trials.
  • Biologics are expected to reach sales of $90 billion by 2010.

Sources: The Biotechnology Industry Organization, February; Express Scripts 2005 Drug Trend Report, June 2006

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