Debate Heats Up in Congress Over Biotech Drugs

Published August 1, 2009

U.S. Sens. Charles Schumer (D-NY) and Susan Collins (R-ME) have introduced legislation that would grant biopharmaceutical firms a five-year window of patent exclusivity before the U.S. Food and Drug Administration is permitted to approve follow-on versions of innovative biotech drugs.

Proponents of the measure say a brief period of patent exclusivity will mean quicker savings on biotech drug costs, as follow-on versions can be purchased less expensively than name-brand originals. Experts in the field, however, say the proposal threatens patients’ health, perhaps even their lives.

Important Differences

There is no such thing as an exact generic equivalent when it comes to biotech drugs, notes Dr. Richard Dolinar, an endocrinologist and senior fellow for health care policy at The Heartland Institute.

“The term generic is often used incorrectly, such as in ‘generic biologics,'” Dolinar said. “This is because it helps to reframe the argument in favor of those who are willing to risk having drugs come to the marketplace without adequate testing in order to save money. The term ‘generic’ helps them because the public thinks of it as simply meaning ‘equal and less costly.’

“However, true generic drugs have the same exact active ingredients as the innovator drug, whereas ‘biosimilar’ drugs do not,” Dolinar said. “A better term for them would be ‘biodifferent’; after all, they are not exact duplicates, but rather variants of the innovator drug.”

Safety Concerns

Edmund Haislmaier, a senior research fellow in health policy studies at The Heritage Foundation, says the differences between generics and biosimilars require different legal treatment.

“The concept of exclusivity is different here than with chemical drugs,” said Haislmaier. “People think of a generic as an exact copy. In a chemical entity that is somewhat possible, but in a biological entity, it is a living entity, so it is not subject to being copyable.

“‘Biosimilar’ drugs … are significantly similar to, but not replications of, the original biotech drug. How to regulate that? Capitol Hill [is currently] deciding what sort of legal framework our country should have when it comes to biotech drugs,” Haislmaier added.

“There are significant safety concerns with ‘generic’ biotech drugs,” said Kristie Prinz, a Silicon Valley-based biotech lawyer. “Biotech generics are never exact copies. That’s why there is always some debate, and that is why there is always debate over whether people should even use bio-drug equivalents.”

Big Savings Doubted

Haislmaier says shortening the biotech exclusivity period will not save the amount of money its proponents expect.

“Because of the nature of the science, nobody should count their savings chickens before they are hatched,” Haislmaier said. “Assuming Capitol Hill comes to some agreement on these issues, the nature of what it takes to manufacture a biological drug might end up having a higher cost structure. But even if Capitol Hill makes it so that ‘generic’ drugs can be produced sooner rather than later, we are still not going to see a huge drop in prices. ‘Generic’ biotech drugs are not cheaper. There will not be huge savings.

“This is a whole different science and a whole different set of economics, and it needs a whole new set of legal regulations,” Haislmaier added. “Capitol Hill is dealing with regulating living organisms in which one batch is not necessarily the same as the other.”

A bill allowing 12 years’ patent exclusivity was passed by the Senate Health, Education, Labor, and Pensions Committee in 2008, but it was not voted on by the full Senate.

Thomas Cheplick ([email protected]) writes from Massachusetts.

For more information …

Senate Bill 726:

“Safety First: A Legislator’s Brief on Biosimilars,” Richard Dolinar, M.D., The Heartland Institute, June 2009: