WASHINGTON — The Food and Drug Administration released its proposal Thursday for naming lower-cost biotech drugs, a critical step in creating a market for the new class of medicines.
These quasi-generic biotech drugs have the potential to save the U.S. health care system billions of dollars in costs. But representatives for the generic drug industry warned that the FDA’s proposal could curb those savings by making the drugs more difficult to prescribe.
Biotech drugs are powerful, injected medicines produced in living cells. They are typically much more expensive than traditional chemical-based drugs. Many newer biotech drugs cost more than $100,000 per year, and together they account for nearly 30 percent of all U.S. drug spending.
For decades, they have not faced generic competition because the FDA lacked a system to approve cheaper versions until 2012. Earlier this year the agency approved the first “biosimilar.” Many questions remain about how the new drugs will be sold and marketed.
