FDA lays out naming rules for lower-cost biotech drugs
WASHINGTON - The Food and Drug Administration has released its proposal for naming lower-cost biotech drugs, a critical step in creating a market for the new class of medicines.
Biotech drugs are powerful, injected medicines produced in living cells which are typically much more expensive than traditional chemical-based drugs.
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 lower-cost biotech drug, a knock-off of the blood booster, Neupogen.
But many questions remain about how the new drugs will be sold, including whether they can use the same ingredient names as the original products.
Under an FDA proposal, biotech drugs would include a four-letter code to help doctors distinguish them from the original versions.