Biogenerics on the slow road to market
Biologics are among the most expensive drugs in the world — in part because the government has never cleared a path to allow generic drugmakers to compete. That could soon change, but there are safety roadblocks ahead.
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LISA NAPOLI: Biotech drugs are among the most expensive in the world. Until now generic drug companies haven’t been allowed in the business. Marketplace’s Steve Henn reports from Washington, that’s about to change.
STEVE HENN: After a brand-name drug has been on the market for years, its patent expires and its price drops as generic competitors rush in.
Biologics don’t face this competition, and their prices are skyrocketing.
JIM GREENWOOD: A biologic is something entirely different. It is a very complicated protein that is produced inside bioengineered living cells.
Jim Greenwood, the CEO of the Biotechnology Industry Association, says the proteins in biologics can be touchy and not easily copied.
GREENWOOD: We think, therefore, it’s important to do clinical trials to make sure that these products are safe and effective.
That could cost generic companies millions.
Still, Congressman Henry Waxman has introduced a bill allowing generic drug companies into the biotech market.
HENRY WAXMAN: The bill does allow FDA to require clinical trials.
Waxman says the FDA should make the safety decisions, not Congress.
In Washington, I’m Steve Henn for Marketplace.