A top drug regulator told lawmakers Monday it could be a decade or more before science is available to safely approve generic versions of biotech drugs in the way the agency approves knockoffs of traditional drugs.
Food and Drug Administration deputy commissioner Janet Woodcock's testimony could benefit companies such as Amgen Inc. and Genentech Inc., which have never faced generic competition in the U.S. for their products, some of the most complex and expensive on the market.
That lack of competition would change under a bill recently introduced by Rep. Henry Waxman, D-Calif. The bill would task FDA with approving knockoff versions of biotech medicines, many of which cost tens of thousands of dollars for a year's supply.
Waxman, who chairs the House Committee on Oversight, helped launch the generic drug industry more than 20 years ago when he co-wrote legislation allowing generic manufacturers such as Barr Pharmaceutical Inc. and Mylan Laboratories Inc. to market cheaper versions of traditional drugs after the originals loose patent protection. Waxman's new legislation would give generic drug makers access to an estimated $12 billion worth of biotech patents that have already expired.
Unlike traditional chemical-based pharmaceuticals, biotech pharmaceuticals are made from living cells and proteins. The biotech industry has long argued that because these proteins are more prone to minor differences when mass produced, it will be more difficult for generic drug companies to safely reproduce them.
Woodcock said that while FDA can currently establish the safety between versions of simple protein-based drugs, it will likely "be a stepwise progression over a decade or so," before the agency can scientifically verify that a knockoff version of a complex biotech drug is similar to the original. Woodcock testified before The House oversight committee along with representatives from the drug industry and consumer groups.
Ranking member Tom Davis, R-Virginia, argued that the complexity of biotech drugs makes it essential that would-be generic biotech makers be required to conduct clinical trials of their products.
A vice president from Denmark-based Novo Nordisk, a biotech company that makes diabetes therapies, agreed. Nordisk's Inger Mollerup said that if Congress creates a system to approve cheaper protein-based drugs it should be similar to one already used by the European Union.
Under the EU system, generic biotech companies have to conduct extensive studies to show the safety of their versions. Even after these studies are completed and the product is approved, knockoff biotech drugs are not considered interchangeable with the original product, meaning a patient has to get doctor approval before switching from the original drug to a generic.
Waxman's bill would allow the FDA to require clinical safety studies, though it wouldn't make it mandatory.
The question of whether generic drug companies would have to conduct safety trials is critical in determining how much lower generic biotech drugs would be priced than their brand name counterparts. Currently, generic drug companies are able to sell their existing treatments at 20 to 60 percent below the original's price because they are not required to spend time and money conducting safety studies.
Last month, pharmacy benefit manager Express Scripts Inc. issued a report saying generic biotech drugs could save patients and insurance providers $71 billion over 10 years.
The Biotechnology Industry Organization called the study flawed, saying it is impossible to forecast savings from generic biotech drugs without knowing how much testing regulators will require. Even as the industry lobbying group tries to head off Waxman's legislation, several original biotech manufacturers say they support the proposal.
Momenta Pharmaceutical's Vice President Ganesh Venkataraman said his company hopes to develop ways to manufacture protein-based drugs that are interchangeable with the original manufacturer's. To date Momenta's research has focused on developing medicines from complex sugar chains, which are different from proteins.
Insmed Inc.'s Geoffrey Allan went one step further, telling committee members that the generic biotech business "is a business in which we would like to specialize."
"The science has reached a level of sophistication to make this endeavor entirely possible," Allan said. "All we need now is the regulatory go ahead."
Insmed's lead product is a first-of-a-kind biological for children who lack certain growth hormones.
