FDA outlines path for lower-priced biotech drugs

WASHINGTON (AP) — The Food and Drug Administration is preparing to review the first lower-cost versions of biotech drugs, expensive medications that have never before faced generic competition in the U.S.

The guidelines issued by the FDA follow a decades-long effort to lower the price of biotech drugs. The high-tech injectable therapies cost the nation billions of dollars each year.

Since their introduction in the 1980s, biotech drugs have not faced generic competition because the FDA did not have power to approve copies of the medications, which are often made with living cells, rather than by mixing chemicals together.

That changed with the Obama administration's 2010 health overhaul, which ordered the FDA to create a system for approving "biosimilar drugs." That industry term acknowledges the difficulty of producing exact copies of biotech drugs.