FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Gottlieb Says Contracting System Is ‘Rigged’ Against Biosimilars

March 12, 2018

Commissioner Scott Gottlieb called the drug contracting system “rigged” in remarks Wednesday at the America’s Health Insurance Plans National Health Policy Conference in Washington, D.C.

Gottlieb called out “pay-for-delay” schemes branded drugmakers use to delay generic and biosimilar competition, noting that such arrangements increasingly come disguised as rebates or contracting provisions between drugmakers and pharmacy benefit managers to crowd out biosimilars, a practice he called the “rebate trap.”

Gottlieb noted only three of the nine approved biosimilars in the U.S. have reached the market, with patent litigation often stalling launches even after approval. Pharmacy benefit managers and insurers profit from the difference between the wholesale acquisition cost and rebated price, he said, adding that drugmakers usually tie rebates to volume or a drug’s position on a preferred formulary status.

View today's stories