Lawmakers expand definition of biologics in year-end spending bill

Lawmakers included a provision in the government funding bill passed by the House Dec. 17 that would expand the definition of biologic drugs and benefit drugmakers, according to STAT

The provision would change the definition of biologic drugs to include "chemically synthesized polypeptides," which includes such drugs as Novo Dordisk's diabetes medication Victoza and Eli Lilly's osteoporosis drug, Forteo

Biologic drugs, which are made from living cells, get 12 years of market exclusivity, while "small molecule" drugs get five years. The policy change would give more drugs longer periods of market exclusivity, which would give larger profits to drugmakers and force consumers to wait longer to get cheaper generic versions, according to STAT

The provision is included in a $1.4 trillion spending package to be passed by the end of the week to avoid a government shutdown. 

Advocates of lowering drug costs called the provision a sign of the pharmaceutical industry's massive influence in Washington. 

"This is unequivocally a giveaway to prescription drug corporations that will lead to higher drug prices, and a clear example of why policy riders should not be included in appropriations bills,” Steven Knievel a member of nonprofit advocacy group Public Citizen told STAT.

FDA officials told STAT the provision would actually incentivize competition, by making it easier for lower-cost competitors to copy chemically synthesized polypeptide products.

The longer market exclusivity period would likely apply only to drugs approved after the bill becomes law, not existing products on the market, because FDA has said that any medicine "transitioning" to be a biologic can't get new exclusivity, according to STAT

Read the full article here.

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