Lawmakers introduce biogenerics bill

A bipartisan group in Congress wants to give the Food and Drug Administration power to approve copies of costly biotech drugs.

Rep. Henry A. Waxman (D-Beverly Hills), chairman of the House Energy and Commerce Committee, and Rep. Nathan Deal (R-Georgia) introduced legislation to create a pathway for the approval of copies of biotechnology-based medical treatments. Biotech drugs are made in living cells, unlike their chemical-based counterparts.

There is no regulatory process for approving such copies in the U.S. That leaves the drugs’ makers insulated from generic competition.

The bill would give broad authority to the FDA to determine what studies are necessary to establish whether any copy is safe and equally as effective as the original product. The FDA could also determine whether a so-called biosimilar is interchangeable with the original product.