FTC: 12-14 yrs too long to protect biotech drugs
WASHINGTON (Reuters) - Generic versions of expensive biotechnology drugs would reduce the amount of money spent on health care in the United States, a Federal Trade Commission report said on Thursday.
Makers of brand-name biotechnology medicines, which can cost tens of thousands of dollars a year, are pushing for 12 to 14 years of protection from competition for their products as lawmakers craft plans to give the Food and Drug Administration authority to clear cheaper copycat versions.
But an FTC report found "the 12- to 14-year regulatory exclusivity period is too long to promote innovation," particularly since brand-name companies "likely will retain substantial market share" after generic competitors are approved.
The FTC report found that competitors would likely enter the market only for drugs that had more than $250 million in annual sales, and only two to three generic entrants would be expected.
"These FOB (follow-on biologic) entrants are unlikely to introduce their FOB products at price discounts any larger than between 10 and 30 percent of the pioneer products' price," the FTC said in its report.
Still, the FTC said, giving the FDA clear authority to approve generic biologics "would be an efficient way to bring these lower-priced drugs to market."
Biologic drugs -- which are usually injectable -- tend to be more expensive and complicated than traditional chemical medicines because they are made from living cells. They are used to treat everything from cancer to autoimmune diseases such as arthritis.
Brand-name biotech companies like Roche Holding's Genentech Inc and Amgen Inc have fought the creation of a generic industry for such drugs. The generic drug industry, on the other hand, is eager to move into the arena.
The FTC report was posted on the agency's website here