Provision in Spending Bill Would Expand Definition of Biologics

It would mean longer patent protection for chemically synthesized polypeptides
Peter Wehrwein

A provision tucked into the year-end spending agreement that Congress is expected to pass this week would expand the definition of biologics to include “chemically synthesized polypeptides” drugs like Novo Nordisk’s Victoza and Eli Lilly’s Forteo, according to Stat.

Biologics get 12 years of patent protection compared to just five for small-molecule drugs, so the reclassification is meaningful—and possible profitable—for drugmakers.

“Advocates working to lower drug prices didn’t see the change to the ‘biologic’ category coming, and couldn’t pinpoint who pushed the change,” Stat’s Nicholas Florko reported. “But they are decrying it a sign of the pharmaceutical industry’s massive power in Washington.”

The polypeptide category is sizable. Stat, citing the Association for Accessible Medicines, said there are more than 60 peptide drugs currently on the market.